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["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Mising outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 Gerenal notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]
["2021.05.10 15.15","Lundgren_2020_mortality","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 28","RR 1.39 (95% CI: 0.40 to 4.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 12.28","Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","RR 1.17 (95% CI: 0.75 to1.85)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 311 out of 326 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 13.55","Lundgren_2020_Hospital-discharge_day5","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge at day 5","RR 0.98 (95% CI: 0.81 to 1.19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.20","Lundgren_2020_Hospital-discharge_TTE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020","HR 0.97 (95% CI: 0.78 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention to treat analysis was performed: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 12.28","Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","RR 1.49 (95% CI: 0.50 to 4.46)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 311 out of 326 participants randomised.",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.32","Lundgren_2020_SAE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 28","RR 0.93 (95% CI: 0.27 to 3.14)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","PN","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 14.26","Lundgren_2020_AE_3and4","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28","RR 1.27 (95% CI: 0.81 to 1.98)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 314 out of 326 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","PN","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.35","Lundgren_2020_neurological-dysfunction: transient ischemic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.35","Lundgren_2020_neurological-dysfunction: acute delirium CVA","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA","RR 3.71 (95%CI: 0.42 to 32.80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_neurological-dysfunction: cerebrovascular event","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event","RR 0.31 (95% CI: 0.01 to 7.53)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_thromboembolic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Thromboembolic events","RR 2.78 (95% CI: 0.29 to 26.44)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.36","Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28","RR 4.64 (95% CI: 0.22 to 95.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“.","PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\"","Low","Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"NA",null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 293 out of 326 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\"","NA",null,"NA",null,"Low","Low","Data of 17 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","N","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 14.55","Gottlieb_2020_mortality_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains. "]
["2021.04.30 12.15","Gottlieb_2020_mortality_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 12.17","Gottlieb_2020_mortality_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 12.11","Gottlieb_2020_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.02","Gottlieb_2020_hospital-admission_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Admission to hospital","RR 0.17 (95% CI: 0.02 to 1.33)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.56","Gottlieb_2020_hospital-admission_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","admission to hospital at day 29","RR 0.32 (95% CI: 0.07 to 1.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.57","Gottlieb_2020_hospital-admission_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","admission to hospital at day 29","RR 0.34 (95% CI: 0.08 to 1.56)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 11.59","Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29","RR 0.15 (95% CI: 0.02 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.02","Gottlieb_2020_viral-clearance7_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 7","RR 0.92 (95% CI: 0.43 to 1.93)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 244 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 5 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 19.00","Gottlieb_2020_viral-clearance7_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 7","RR 1.08 (95% CI: 0.53 to 2.18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 246 out of 270 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 8 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.57","Gottlieb_2020_viral-clearance7_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 7","RR 0.73 (95% CI: 0.33 to 1.65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 244 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 5 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.58","Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 7","RR 1.27 (95% CI: 0.65 to 2.48)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 245 out of 275 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 14 participants in the treatment arm and of 16 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.49","Gottlieb_2020_viral-clearance15_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 15","RR 1.07 (95% CI: 0.69 to 1.66)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 223 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 13 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.52","Gottlieb_2020_viral-clearance15_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 15","RR 1.20 (95% CI: 0.79 to 1.82)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 229 out of 270 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 12 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.52","Gottlieb_2020_viral-clearance15_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 15","RR 1.03 (95% CI: 0.66 to 1.61)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 226 out of 265 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 10 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.10 18.36","Gottlieb_2020_viral-clearance15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 15","RR 1.43 (95% CI: 0.97 to 2.10)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"N","Data for this outcome was available for 230 out of 275 participants randomised.","PY","It is unlikely that the results are biased by missing outcoma data, as this was a double-blinded study: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study\".","NA",null,"NA",null,"Low","Low","Data of 16 participants in the treatment arm and of 29 participants in the control arm were missing. The study was double-blinded and it is not likely that missingness in the outcome depended on its true value.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory.","N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\".","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","adverse events all grades","RR 0.99 (95% CI: 0.66 to 1.50)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","adverse events all grades","RR 0.90 (95% CI: 0.59 to 1.38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","adverse events all grades","RR 0.81 (95% CI: 0.52 to 1.27)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.04.30 16.48","Gottlieb_2020_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades","RR 0.63 (95% CI: 0.39 to 1.02)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)","RR 0.48 (95% CI: 0.02 to 11.78)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 263 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 263 out of 270 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 257 out of 265 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.02 11.46","Gottlieb_2020_SAE_Bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)","RR 1.39 (95% CI: 0.09 to 22.03)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\".","N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\".","Low","Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\"","NA",null,"NA",null,"NA",null,"Y","Yes, a modified intention-to-treat analysis was performed: \"All randomized participants who received study intervention and provided at least one post-baseline measure for the relevant endpoint. Participants will be analyzed according to the intervention to which they were randomized (Intention to treat).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 268 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 268 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol.","PN","No differences in measurement between groups.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage.","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]
["2021.05.05 14.37","Weinreich_2020_SAE","NK, CH","Weinreich 2020",null,"REGN-CoV-2 (2.4g and 8.0g)","Placebo","serious adverse events (SAE)","RR 0.26 (95% CI: 0.02 to 2.88)","assignment to intervention (the 'intention-to-treat' effect)","NA",1," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Y","Y","The allocation sequences was random and concealed according to the trial: \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\"","N","There are no baseline differences that would suggest a problem with randomisation.","Low","Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation.",null,null,"N","N","Participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\".","NA",null,"NA",null,"NA",null,"Y","Yes, an intention to treat analysis was performed: \"The full analysis set (FAS) includes all randomized patients and is based on the treatment allocated (as randomized).\"","NA",null,"Low","Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate.",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 269 participants analysed).","NA",null,"NA",null,"NA",null,"Low","Low","Data for this outcome was available for 269 out of 275 participants randomised.",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol.","PN","Differences in measurement between groups are unlikely.","N","No, the outcome assessors were unaware of the intervention received.","NA",null,"NA",null,"Low","Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received.",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available.","N","Preplanned endpoint measured and reported as planned at protocol stage","N","Preplanned endpoint measured and reported as planned at protocol stage.","Low","Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol.",null,null,"Low","Low","For this outcome, there is a low risk of bias for all the domains."]

{"sheet":"Summary","index":2,"n_rows":38,"n_cols":27,"rows_kept":38,"cut":false,"hidden":false,"merged":[]}
["Unique ID","Reviewer","Study ID","Reference","Experimental","Comparator","Outcome","Result","Aim","Effect of adhering to intervention?","Weight","Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias",null,null,null,null,"Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias"]
["Lundgren_2020_mortality","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Mortality at day 28","RR 1.39 (95% CI: 0.40 to 4.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
["Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","RR 1.17 (95% CI: 0.75 to1.85)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 37",0,0,0,0,2.4,2.4]
["Lundgren_2020_Hospital-discharge_day5","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge at day 5","RR 0.98 (95% CI: 0.81 to 1.19)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,100,100,100,100,100,100]
["Lundgren_2020_Hospital-discharge_TTE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020","HR 0.97 (95% CI: 0.78 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,0,0,0,0,0,0]
["Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","RR 1.49 (95% CI: 0.50 to 4.46)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,null,0,0,0,0,0,0]
["Lundgren_2020_SAE","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","serious adverse events up to day 28","RR 0.93 (95% CI: 0.27 to 3.14)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_AE_3and4","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28","RR 1.27 (95% CI: 0.81 to 1.98)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low",null,null,null,"Total number of study = 0"]
["Lundgren_2020_neurological-dysfunction: transient ischemic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_neurological-dysfunction: acute delirium CVA","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA","RR 3.71 (95%CI: 0.42 to 32.80)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_neurological-dysfunction: cerebrovascular event","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event","RR 0.31 (95% CI: 0.01 to 7.53)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_thromboembolic events","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Thromboembolic events","RR 2.78 (95% CI: 0.29 to 26.44)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","NK, CH, ET, KC, MP, MN, ZK","ACTIV-3",null,"Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28","RR 4.64 (95% CI: 0.22 to 95.83)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_mortality_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and Etesevimab","Placebo","Mortality at day 28","Not estimable","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","Admission to hospital","RR 0.17 (95% CI: 0.02 to 1.33)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","admission to hospital at day 29","RR 0.32 (95% CI: 0.07 to 1.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","admission to hospital at day 29","RR 0.34 (95% CI: 0.08 to 1.56)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29","RR 0.15 (95% CI: 0.02 to 1.20)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 7","RR 0.92 (95% CI: 0.43 to 1.93)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 7","RR 1.08 (95% CI: 0.53 to 2.18)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 7","RR 0.73 (95% CI: 0.33 to 1.65)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 7","RR 1.27 (95% CI: 0.65 to 2.48)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","viral clearance at day 15","RR 1.07 (95% CI: 0.69 to 1.66)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","viral clearance at day 15","RR 1.20 (95% CI: 0.79 to 1.82)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","viral clearance at day 15","RR 1.03 (95% CI: 0.66 to 1.61)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_viral-clearance15_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","viral clearance at day 15","RR 1.43 (95% CI: 0.97 to 2.10)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","adverse events all grades","RR 0.99 (95% CI: 0.66 to 1.50)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","adverse events all grades","RR 0.90 (95% CI: 0.59 to 1.38)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","adverse events all grades","RR 0.81 (95% CI: 0.52 to 1.27)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_AEall_bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","adverse events all grades","RR 0.63 (95% CI: 0.39 to 1.02)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_0.7g","NK, CH","BLAZE-1",null,"Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_2.8g","NK, CH","BLAZE-1",null,"Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)","RR 0.48 (95% CI: 0.02 to 11.78)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_7.0g","NK, CH","BLAZE-1",null,"Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)","RR 0.51 (95% CI: 0.02 to 12.47)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Gottlieb_2020_SAE_Bamlanivimab+etesevimab","NK, CH","BLAZE-1",null,"Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)","RR 1.39 (95% CI: 0.09 to 22.03)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]
["Weinreich_2020_SAE","NK, CH","Weinreich 2020",null,"REGN-CoV-2 (2.4g and 8.0g)","Placebo","serious adverse events (SAE)","RR 0.26 (95% CI: 0.02 to 2.88)","assignment to intervention (the 'intention-to-treat' effect)","NA",1,"Low","Low","Low","Low","Low","Low"]

{"sheet":"Figure (ITT)","index":3,"n_rows":37,"n_cols":16,"rows_kept":37,"cut":false,"hidden":false,"merged":[]}
["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]
[null,"Lundgren_2020_mortality","ACTIV-3","Bamlanivimab 7g","Placebo","Mortality at day 28",1,null,null,null,null,null,null,null,null,"Low risk"]
[null,"Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","ACTIV-3","Bamlanivimab 7g","Placebo","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)",1,null,null,null,null,null,null,null,null,"Some concerns"]
[null,"Lundgren_2020_Hospital-discharge_day5","ACTIV-3","Bamlanivimab 7g","Placebo","Hospital discharge at day 5",1,null,null,null,null,null,null,null,null,"High risk"]
[null,"Lundgren_2020_Hospital-discharge_TTE","ACTIV-3","Bamlanivimab 7g","Placebo","Hospital discharge TTE up to 26 October 2020",1]
[null,"Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","ACTIV-3","Bamlanivimab 7g","Placebo","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)",1,null,null,null,null,null,null,null,"D1","Randomisation process"]
[null,"Lundgren_2020_SAE","ACTIV-3","Bamlanivimab 7g","Placebo","serious adverse events up to day 28",1,null,null,null,null,null,null,null,"D2","Deviations from the intended interventions"]
[null,"Lundgren_2020_AE_3and4","ACTIV-3","Bamlanivimab 7g","Placebo","Grade 3 and 4 adverse events up to day 28",1,null,null,null,null,null,null,null,"D3","Missing outcome data"]
[null,"Lundgren_2020_neurological-dysfunction: transient ischemic events","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: transient ischemic events",1,null,null,null,null,null,null,null,"D4","Measurement of the outcome"]
[null,"Lundgren_2020_neurological-dysfunction: acute delirium CVA","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: acute delirium CVA",1,null,null,null,null,null,null,null,"D5","Selection of the reported result"]
[null,"Lundgren_2020_neurological-dysfunction: cerebrovascular event","ACTIV-3","Bamlanivimab 7g","Placebo","Neurological dysfunction at day 28: cerebrovascular event",1]
[null,"Lundgren_2020_thromboembolic events","ACTIV-3","Bamlanivimab 7g","Placebo","Thromboembolic events",1]
[null,"Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","ACTIV-3","Bamlanivimab 7g","Placebo","Renal dysfunction (or need for dialysis) at day 28",1]
[null,"Gottlieb_2020_mortality_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_mortality_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and Etesevimab","Placebo","Mortality at day 28",1]
[null,"Gottlieb_2020_hospital-admission_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","Admission to hospital",1]
[null,"Gottlieb_2020_hospital-admission_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_hospital-admission_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","admission to hospital at day 29",1]
[null,"Gottlieb_2020_viral-clearance7_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","viral clearance at day 7",1]
[null,"Gottlieb_2020_viral-clearance15_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_viral-clearance15_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_viral-clearance15_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","viral clearance at day 15",1]
[null,"Gottlieb_2020_AEall_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_AEall_bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","adverse events all grades",1]
[null,"Gottlieb_2020_SAE_0.7g","BLAZE-1","Bamlanivimab 0.7g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_2.8g","BLAZE-1","Bamlanivimab 2.8g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_7.0g","BLAZE-1","Bamlanivimab 7.0g","Placebo","serious adverse events (SAEs)",1]
[null,"Gottlieb_2020_SAE_Bamlanivimab+etesevimab","BLAZE-1","Bamlanivimab and etesevimab","Placebo","serious adverse events (SAEs)",1]
[null,"Weinreich_2020_SAE","Weinreich 2020","REGN-CoV-2 (2.4g and 8.0g)","Placebo","serious adverse events (SAE)",1]

{"sheet":"Figure (PP)","index":4,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Print 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["Unique ID","Lundgren_2020_mortality","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Development of severe symptoms: Need for NIV, IMV, ECMO, or renal replacement therapy at day 5 (group 5, 6 or 7)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 311 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Hospital-discharge_day5","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Hospital discharge at day 5","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Hospital-discharge_TTE","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Hospital discharge TTE up to 26 October 2020","Results","hazard ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, a modified intention to treat analysis was performed: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Development of severe symptoms: Clinical status at day 5, intubation (group 6 at pulmonary scale)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 311 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 311 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_SAE","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events up to day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_AE_3and4","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Grade 3 and 4 adverse events up to day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 314 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 314 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: transient ischemic events","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: transient ischemic events","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: acute delirium CVA","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: acute delirium CVA","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_neurological-dysfunction: cerebrovascular event","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Neurological dysfunction at day 28: cerebrovascular event","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_thromboembolic events","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Thromboembolic events","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Lundgren_2020_Renal dysfunction (or need for dialysis) at day 28","Study ID","ACTIV-3","Assessor","NK, CH, ET, KC, MP, MN, ZK"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Renal dysfunction (or need for dialysis) at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"mass-weighted urn randomization will be used to generate the active and placebo assignments.\" and \"Investigational agents or placebo (as necessary) will be prepared by a pharmacist who is unblinded to the treatment assignment“."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","There are differences in baseline characteristics, but they are unlikely to indicate problems with the randomisation process: \"Several baseline characteristics indicated that by chance more patients in the LY-CoV555 group than in the placebo group may have been at greater risk for disease progression.\""]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via mass-weighted urn randomisation. There are baseline differences, but they are unlikely to suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"For investigational agents infused, blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, the modified intention to treat population was reported: \"Unless otherwise stated, the analysis cohort for this preliminary report is the modified intention-to-treat population, which includes all the patients who received all or part of the LY-CoV555 or placebo infusion.\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (326 participants randomised and 293 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 293 out of 326 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains. "]
[]
[]
["Unique ID","Gottlieb_2020_mortality_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_mortality_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and Etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Mortality at day 28","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","Admission to hospital","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_hospital-admission_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","admission to hospital at day 29","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","The method of measuring of the outcome was not described in the trial, but probably assessed objectively on a case report form."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was likely appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 244 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 244 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 246 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 246 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 244 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 244 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance7_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 7","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 245 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 245 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 223 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 223 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 229 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 229 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_viral-clearance15_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","viral clearance at day 15","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 226 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 226 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol: viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","No differences in measurement between groups: \"viral clearance will be evaluated by nasopharyngeal swabs, assayed by Lilly-designated laboratory\"."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","Preplanned endpoint measured and reported as planned at protocol stage. Day 11 reported as additional time point."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised vs. 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised vs. 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_AEall_bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","adverse events all grades","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised vs. 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_0.7g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 0.7g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_2.8g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 2.8g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (270 participants randomised and 263 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 263 out of 270 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_7.0g","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab 7.0g","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (265 participants randomised and 257 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 257 out of 265 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Gottlieb_2020_SAE_Bamlanivimab+etesevimab","Study ID","BLAZE-1","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Bamlanivimab and etesevimab","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAEs)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"centrally randomized to study intervention using an Interactive Web Response System (IWRS)\"."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation: \"The two trial groups were well balanced regarding risk factors at the time of enrollment\"."]
[null,"Risk of bias judgement",null,null,"Low","Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, intention-to-treat population reported"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 268 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 268 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in trial registry or protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","No differences in measurement between groups."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]
[]
[]
["Unique ID","Weinreich_2020_SAE","Study ID","Weinreich 2020","Assessor","NK, CH"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","REGN-CoV-2 (2.4g and 8.0g)","Comparator","Placebo","Source"," Journal article(s); Trial protocol; Statistical analysis plan (SAP); Non-commercial trial registry record (e.g. ClinicalTrials.gov record)"]
["Outcome","serious adverse events (SAE)","Results","risk ratio","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","The allocation sequences was random and concealed according to the trial: \"Patients will be randomized according to a central randomization scheme using an interactive web response system (IWRS)\""]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","There are no baseline differences that would suggest a problem with randomisation."]
[null,"Risk of bias judgement",null,null,"Low","Participants were centrally randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation."]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"N","Participants and people delivering the intervention were unaware of intervention received: \"Study patients, the principal investigators, and study site personnel (with the exception of the unblinded pharmacist at each site) will remain blinded to all randomization assignments throughout the study\"."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"N"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NA"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","Yes, an intention to treat analysis was performed: \"The full analysis set (FAS) includes all randomized patients and is based on the treatment allocated (as randomized).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate."]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","Data for this outcome was available for nearly all participants (275 participants randomised and 269 participants analysed)."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","Data for this outcome was available for 269 out of 275 participants randomised."]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","The outcome measurement is an appropriate measure and was measured as described in protocol."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","Differences in measurement between groups are unlikely."]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"N","No, the outcome assessors were unaware of the intervention received."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low","The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received."]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"Y","The result analysed was in accordance to the protocol and statistical analysis plan available."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","Preplanned endpoint measured and reported as planned at protocol stage."]
[null,"Risk of bias judgement",null,null,"Low","The data that produced this result was analysed in accordance with the pre-specified analysis plan and the outcome was reported as planned in the protocol."]
["Overall bias","Risk of bias judgement",null,null,"Low","For this outcome, there is a low risk of bias for all the domains."]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","adhering to intervention (the 'per-protocol' effect)","The effect of adhering to intervention…"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1 Were participants aware of their assigned intervention during the trial?"]
[null,"2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups?"]
[null,"2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?"]
[null,"2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?"]
[null,"2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

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[null,"Journal article(s)","NA","Yes",null,"1.1 Was the allocation sequence random?",null,"2.1 Were participants aware of their assigned intervention during the trial?","2.1 Were participants aware of their assigned intervention during the trial?",null,"3.1 Were data for this outcome available for all, or nearly all, participants randomized?","Individually Randomized, Parallel Group Trials","4.1 Was the method of measuring the outcome inappropriate?","assignment to intervention (the 'intention-to-treat' effect)","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,null,"occurance of non-protocol interventions"]
["NA","Trial protocol","Favours experimental ","No (Please include reasons in the note)","Y","1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?","Low","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,"3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?",null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?","adhering to intervention (the 'per-protocol' effect)","5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,null,"failures in implementing the intervention that could have affected the outcome"]
["Y","Statistical analysis plan (SAP)","Favours comparator ",null,"PY","1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?","High","2.3 [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important nonprotocol interventions balanced across intervention groups?","2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?",null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,"4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?",null,"5.3 ... multiple eligible analyses of the data?",null,null,null,"non-adherence to their assigned intervention by trial participants"]
["PY","Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Towards null ",null,"PN",null,"Some concerns","2.4 [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?","2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
["PN","Company-owned trial registry record (e.g. GSK Clinical Study Register record)","Away from null ",null,"N",null,null,"2.5 [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?","2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
["N","“Grey literature” (e.g. unpublished thesis)","Unpredictable",null,"NI",null,null,"2.6 If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?","2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
["NI","Conference abstract(s) about the trial",null,null,null,null,null,null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Regulatory document (e.g. Clinical Study Report, Drug Approval Package)"]
[null,"Research ethics application"]
[null,"Grant database summary (e.g. NIH RePORTER, Research Councils UK Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]