Number of patients with myocardial infarction;Number of patients with stroke;Number of patients with bleeding complications;Number of patients with acute kidney injury;Number of patients with vascular complications
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Attention in TAP;Orthostatic symptoms (Winkler Scale);daytime sleepiness
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline;Binary NIHSS at Day 90;Stroke-related quality of life at 3 months: Stroke Impact Scale-16
Safety endpoint: Number of AEs and proportion of patients with at least one AE;Efficacy/performance endpoint, clinical:Proportion of patients with CDI;Efficacy/performance endpoint, clinical: Proportion of patients with AAD;Efficacy/performance endpoint, clinical: Plasma levels of FQs;Efficacy/performance endpoint, biological: Level of free fecal concentrations of FQs;Efficacy/performance endpoint, biological: Level of a-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Change from D1 of a-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Levels of ß-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Proportion of patients with resistant bacteria and/or yeasts in feces;Efficacy/performance endpoint, biological: Proportion of patients with at least one occurrence of resistant bacteria and yeasts in feces (among patients negative at baseline);Efficacy/performance endpoint, biological: Proportion of patients with acquisition of intestinal colonization by C. difficile (among patients negative at baseline)
Flow mediated vasodilation;Wall to lumen ratio of retinal arterioles;Retinal capillary flow;Office and 24-hour systolic, diastolic and mean ambulatory blood pressure;Central systolic pressure;Pulse pressure;Pulse wave velocity;Glomerular filtration rate;Filtration fraction;Renal vascular resistance;Intraglomerular pressure
Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing;t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing;Number of treatment emergent adverse events
Microbial metagenomics sequencing;Identifying genetic defect
Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 from Baseline for Participants with Worst Pruritus NRS = 4 at Baseline;Percentage of Participants Achieving EASI 90;Percentage of Participants Achieving EASI 100;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score = 14 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score = 11 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) = 28 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score = 4 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score = 12 (Minimal Clinically Important Difference (MCID)) from Baseline;Percentage of Participants Experiencing a Flare;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose B;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose A;Percentage of Participants Achieving EASI 75
Components of sustained remission (composite measure);Cumulative corticosteroid dose;Time to first polymyalgia rheumatica (PMR) flare;Change in glucocorticoid toxicity index;Adverse events;Pharmacokinetic
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity);Cmax (maximum measured concentration of the analyte in plasma)
rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction;effect of ripasudil on corneal endothelial cell density (ECD);effect of ripasudil on corneal thickness;assess the need of rescue therapy (DMEK);effect of ripasudil on contrast sensitivity;effect of on visual acuity (BCVA)
Bile acid reduction (US);Change in pruritus (EU and rest of world);Change in fasting serum bile acids (s-BA);Change in serum ALT concentration;Change in growth;Proportion of patients achieving meaningful reduction in caregiver-reported observed scratching;Change in sleep disturbances;Change in sleep disturbances, including number of awakenings;Change in patient-reported itch severity;Number of patients undergoing biliary diversion surgery or liver transplantation
Clinical motor and non-motor symptoms (1);Clinical motor and non-motor symptoms (2);Clinical motor and non-motor symptoms (3);Clinical motor and non-motor symptoms (4);Clinical motor and non-motor symptoms (5);Clinical motor and non-motor symptoms (6);Clinical motor and non-motor symptoms (7);Clinical motor and non-motor symptoms (8);Neurocognitive and non-motor symptoms (1);Neurocognitive and non-motor symptoms (2);Neurocognitive and non-motor symptoms (3);Neurocognitive and non-motor symptoms (4);Neurocognitive and non-motor symptoms (5);Neurocognitive and non-motor symptoms (6);Neurocognitive and non-motor symptoms (7);Neuropsychiatric symptoms (1);Neuropsychiatric symptoms (2);Freezing of gait (1);Freezing of gait (2);Quality of life
diagnostic accuracy of intraarterial pressure measurement;diagnostic accuracy of intraarterial pressure measurement with IVUS;Target lesion stenting rate;Number of stents used per target lesion;Average stent length per target lesion;Average target lesion length stented (full, spot);DCB technical success;Stent technical success;Procedural success;Primary Patency;Major Adverse Event (MAE);Major Adverse Cardiac Event (MACE);Major Adverse Limb Event (MALE);Clinically driven Target Lesion Revascularization;Major target limb amputation rate;all cause of death rate;Hemodynamic improvement;Rate of primary sustained clinical improvement;Rate of secondary sustained clinical improvement;Health Related Quality of Life;Walk Impairment;Resource utilisation
Change in 2-Item Warmth Perception Measure (feet) from t1 to t2;Change in 2-Item Warmth Perception Measure (face) from t1 to t3;Change in 2-Item Warmth Perception Measure (face) from t1 to t2;Change in 2-Item Warmth Perception Measure (hands) from t1 to t3;Change in 2-Item Warmth Perception Measure (hands) from t1 to t2;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2;Change in Distal Skin Temperature Measure (feet) from t1 to t3;Change in Distal Skin Temperature Measure (feet) from t1 to t2;Change in Distal Skin Temperature Measure (face) from t1 to t3;Change in Distal Skin Temperature Measure (face) from t1 to t2;Change in Distal Skin Temperature Measure (hands) from t1 to t3;Change in Distal Skin Temperature Measure (hands) from t1 to t2
Proportion of participants with resolution of steatohepatitis;Proportion of participants who have at least a one point improvement in fibrosis
Oral health of obese adults after bariatric surgery - attachment loss;Oral health of obese adults after bariatric surgery - BOP;Oral health of obese adults after bariatric surgery - dental caries;Oral health of obese adults after bariatric surgery - erosive tooth wear
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Change from baseline for itch-related quality of life: ItchyQoL total score;Change from baseline for Prurigo Nodularis skin lesions;Change from baseline for sleep disturbance
Accuracy of patients' drug response prediction by ex-vivo drug profiling;Prediction of time to next treatment
Time to first bowel movement;Thriving;Z-Score (standard deviation score);Number of days of postoperative total parenteral nutrition (TPN);Laboratory parameter indicating cholestasis;Assessment of adverse events (AEs);Assessment of serious adverse events (SAEs);Postoperative weight gain (g/d);Central venous line (CVL);hospitalisation;jump in caliber;Sodium resorption;Status of liver enzymes;Laboratory parameters
Quality of Life - mental function;Angina;Wound infection;Atrial fibrillation;Length of hospital stay;Length of ICU stay;Duration of intubation;Post-operative pain;Re-exploration for bleeding;Post-operative transfusion;Intra-operative transfusion;Percentage of arterial grafts;Number of bypass grafts;Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR)
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Change in 24-hr urinary oxalate excretion
Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor;Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Change From Baseline in Asthma Control Test (ACT) Total Score;Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6;Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6;Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6
Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.
recruitability;feasibility to set up a larger phase II study;RV contractility;Collection of Adverse Events
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs);Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs
Change in HbA1c (%);Change in fasting plasma glucose (FPG);HbA1c <7%;Change in body weight;Hypoglycemic participants;Hypoglycemic events;Adverse Events (AEs)
Objective Response;Progression Free Survival;Overall Survival;Duration of response;Blinatumomab Steady state concentration;Blinatumomab Clearance rate;Pembrolizumab Peak Plasma Concentration;Pembrolizumab Minimum plasma concentration;Pembrolizumab PK Parameter - AUC;Complete response
Total number of prescriptions;Frequency of switching between COPD medications;Frequency of use of concomitant medications;Adherence to COPD medication within 1 year;Average daily dose of COPD medication;Duration of COPD medication use
Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs;Occurrence of Subjects With TEAEs by Severity According to Qualitative Toxicity Scale Selected From National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;Number of Subjects with Clinically Significant Change From Baseline in Laboratory Tests, Vital Sign and 12-lead Electrocardiogram (ECG) Findings;Time to Reach the Maximum Plasma Concentration (tmax) of M7583;Terminal Rate Constant (?z) of M7583;Apparent Terminal Half-life (t1/2) of M7583;Total Body Clearance of Drug From Plasma Following Oral Administration (CL/f) of M7583;Apparent Volume of Distribution (Vz/f) of M7583;Area Under the M7583 Plasma Concentration-time Curve From Time Zero to 24 hours After Dosing (AUC0-24h);Percentage of AUC0-8 Obtained by Extrapolation (%AUCextra) of M7583;Relative Bioavailability of M7583 Tablet versus M7583 PIC (Frel,T/P);Relative Bioavailability of M7583 Tablet Administered 30 Minutes After a Standard Breakfast Versus Tablet Administered After an Overnight Fast (Frel,Fed/Fasted)
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Change From Baseline in Daytime Asthma Symptom Score;Change From Baseline in Number of Puffs of SABA Taken Per Day;Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
Progression-free survival;Overall survival;Drug intake;Global health status
The difference of prevalences after one month
Spirometry: FEV1;Spirometry: FEV1;Spirometry: FEV1/VCin;Spirometry: FEV1/VCin;Spirometry: PEF;Spirometry: PEF;Heart Rate Variability (SDNN);Heart Rate Variability (SDNN);Heart Rate Variability (RMSSD);Heart Rate Variability (RMSSD);Heart Rate Variability (LF/HF);Heart Rate Variability (LF/HF);Vascular stiffness;Vascular stiffness;Blood Pressure;Blood Pressure;Haemodynamics Stroke volume;Haemodynamics Stroke volume;Haemodynamics Cardiac output;Haemodynamics Cardiac output;Haemodynamics Total Vascular Resistance;Haemodynamics Total Vascular Resistance;Haemodynamics Cardiac index;Haemodynamics Cardiac index;Haemodynamics Perfusion;Haemodynamics Perfusion;Haemodynamics Plethvariability;Haemodynamics Plethvariability;Oxygen Saturation;Oxygen Saturation;ACQ;ACQ;AQLQ;AQLQ;ARCIM Questionnaire;ARCIM Questionnaire;STAI Questionnaire;STAI Questionnaire;ASF Questionnaire;ASF Questionnaire;Asthma medication;Asthma medication
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Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Progression-free survival;Disease-free survival;Metastasis-free survival;Overall survival;Chemotherapy toxicity
Patients' adherence and persistence to lenalidomide and dexamethasone therapy
Height velocity at 6 months;Change in height Standard Deviation Score (SDS);Change in bone maturation (BM);IGF-1 serum levels;IGF-1 SDS serum levels;IGFBP-3 levels;IGFBP-3 SDS
Percentage of Participants With Positive Influenza Virus Titer at Each Time Point;Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point;Change From Baseline in Virus Titer at Each Time Point;Change From Baseline in Virus RNA (RT-PCR) at Each Time Point;Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer;Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA;Time to Cessation of Viral Shedding Determined by Virus Titer;Time to Cessation of Viral Shedding Determined by Virus RNA;Percentage of Participants Whose Symptoms Were Improved at Each Time Point;Time to Alleviation of Symptoms;Time to Improvement of the Four Systemic Symptoms;Time to Improvement of the Three Respiratory Symptoms;Time to Resolution of Fever;Percentage of Participants Reporting Normal Temperature at Each Time Point;Body Temperature at Each Time Point;Time to Improvement of Individual Symptoms;Time to Return to Preinfluenza Health Status;Percentage of Participants Requiring Systemic Antibiotics for Infections Secondary to Influenza Infection;Percentage of Participants With Influenza-related Complications;Percentage of Participants With Adverse Events (AEs)
Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline;Change in EuroQOL (EQ-5D) compared to baseline;Change in Core Outcome Measure Index (COMI) compared to baseline;Change in flexion and extension radiographs compared to baseline (angle difference [deg]).;Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]);Change in consumption of analgetics compared to baseline;Return to work;Return to work;Return to work;Return to work;Return to work;Mortality;Mortality;Mortality;Mortality;Mortality;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline;Change in EuroQOL (EQ-5D) compared to baseline;Change in Core Outcome Measure Index (COMI) compared to baseline;Change in flexion and extension radiographs compared to baseline (angle difference [deg]).;Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]);Change in consumption of analgetics compared to baseline;Return to work;Return to work;Return to work;Return to work;Return to work;Mortality;Mortality;Mortality;Mortality;Mortality;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Adverse effects
Safety measured by follow-up interview with referring physician and documentation of AE;Implantation time
Annualized Rate of Moderate and Severe Asthma Exacerbations;Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24;Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24;Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24;Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period;Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE;Number of Participants With Abnormal Electrocardiogram (ECG) Findings;Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24;Mean Change From Baseline in Pulse Rate at Week 24;Number of Participants With Abnormal Clinical Chemistry Values;Number of Participants With Abnormal Hematology Values
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OSDI questionnaire;Tear film stability;Visual acuity (best corrected);TearLab osmolarity test;Inflammation marker matrix metalloproteinase 9 (MMP9);Lid-parallel conjunctival fold (LIPCOF) grading;Corneal staining;Tear volume;Conjunctival staining
Duration of AAD;Time to event of AAD;Occurrence of Clostridium difficile Associated Diarrhea;Time to event of Clostridium difficile Associated Diarrhea;Duration of Clostridium difficile Associated Diarrhea;Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting);Score of gastrointestinal symptoms
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];Effect on Body Fat Mass;Effect on Hunger;Improvements in insulin resistance;Effect on Waist Circumference;Reversal of weight during the double-blind placebo controlled withdrawal phase
Patient Global Assessment;PASI 50;PASI 75;Patient reported itching;Patient reported sleep loss;Patient reported erythema;Patient reported scaling;Patient reported dry skin;Patient reported overall treatment satisfaction;Patient reported satisfaction with effectiveness;Patient reported satisfaction with tolerability;Patient reported satisfaction with convenience;Dermatology Life Quality Index
Disease-free survival (DFS);Overall survival (OS);Disease-free interval in a per protocol analysis;Adverse event profile
Change in Bond & Lader VAS parameter;Change in Number Connection Test;Change in FAIR-2;Change in SF-12 parameter;Change in PSQ20 parameter;Change in POMS-35 parameters;Global evaluation of benefit;Adverse events;Global evaluation of tolerability
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
The Percentage of Patients With a PASI 75 Response at Week 24;The Mean Percentage Improvement in PASI at Week 16;The Percentage of Patients With a Static Physician's Global Assessment (sPGA) =1 (Clear or Almost Clear) at Week 16;The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16;The Percentage of Patients With Drug-related Adverse Events (AEs)
Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS);Recording of complications;Urine status measured by flow cytometry;Residual urine measured by bladder scan in ml
Number of days with administration of Ovaleap®;Administered total dose of Ovaleap®;Level of serum estradiol at the time of the last examination prior to induction of ovulation;Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation;Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist);Number of Metaphase II (MII)-oocytes;Percentage fertilisation rate;Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos;Luteal phase support (LPS): product, dose and duration of administration;User satisfaction with the Ovaleap®-pen;Baby-Take-Home-Rate (live-births).;Rate of multiple pregnancies (twins, triplets, quadruplets).;Frequency and intensity of adverse drug reactions (ADRs)
Percentage of Participants Achieving HiSCR-es at Week 12;Percentage of Participants Achieving HiSCR-es at Week 24;Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12;Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL);Change From Baseline in Functional Activities Questionnaire (FAQ) Score;Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score;Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score;Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage;Change From Baseline in Neuropsychiatric Inventory (NPI) Score;Change From Baseline on the Mini-Mental State Examination (MMSE);Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aß)1-42;Percent Change From Baseline in Concentration of CSF Biomarker Aß1-40;Change From Baseline in CSF Biomarker Total Tau;Change From Baseline in CSF Biomarker Phosphorylated Tau;Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan;Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan;Change From Baseline in Whole Brain Volume;Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat;Population PK: Central Volume of Distribution of Lanabecestat
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Self-assessed depression;Dysfunctional beliefs;Dysfunctional metacognitive beliefs;Quality of life;Work status;Self-esteem;Remission rate
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24);Number of Participants With Viral Relapse;Number of Participants With Late Viral Relapse;Percentage of Participants With On-treatment Failure;Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
Alteration (G2 - G1) of Nugent Score;Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2
Maximum Observed Plasma Concentration (Cmax);Time to Reach Maximum Observed Plasma Concentration (Tmax);Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC [0-12]);Area Under the Plasma Concentration Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast);Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]);Elimination Half-life Period (T1/2);Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Change From Baseline in Heart rate;Change From Baseline in QRS Interval;Change From Baseline in PR Interval;Change From Baseline in RR Interval
Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to Week 40 in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to end of first period (Week 16) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Total Improvement Score (TIS);Mean change from end of first period (Week 16) to end of extension period (Week 40) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: SF-36v2 Health Survey;Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: Individual six core set measures (CSM) from Total Improvement Score (TIS);Proportion of Total Improvement Score (TIS) responders at the end of the extension period (Week 40) relative to Week 16 or Week 0
Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin;Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin;Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide;SOFA Score;Renal replacement therapy;Concomitant medication;In-hospital mortality
Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire;Percentage of Participants With Treatment Response;Area Under the Concentration-Time Curve (AUC) of Ribavirin;Maximum Concentration (Cmax) of Ribavirin;Time to Maximum Concentration (Tmax) of Ribavirin;Area Under the Concentration-Time Curve (AUC) of PEG-IFN;Maximum Concentration (Cmax) of PEG-IFN;Time to Maximum Concentration (Tmax) of PEG-IFN;Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT);Maximum Concentration (Cmax) of GPT;Time to Maximum Concentration (Tmax) of GPT
All-cause mortality;Percent of patients with interventions for heart failure decompensation;Clinical Composite Score;Atrial fibrillation;Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ);Change in Quality of Life measured by the EQ-5D;All-cause re-admissions within 30-days after a heart failure admission
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Surgical times;Normalized Consumption Index;Reduced Normalized Consumption Index;Quality of life questionnaire;Intraprocedural and periprocedural serious adverse events regardless of relationship with the device;All valve and procedure relevant serious adverse events as specified in Valve Academic Research Consortium-2 (VARC-2) guidelines;Serious device related adverse events;Freedom from MACCE;Rate of Pacemaker implantation;Echocardiographic endpoints (site-reported data);Echocardiographic endpoints in a reduced cohort of patients assessed by core lab
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Reduction of key side effects;Maximum of antibody-related pain;Comparative pharmacokinetics
The European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score over time;Stimulated salivary flow over time;Oral dryness numeric response scale over time;B cell quantification within salivary gland biopsy at Week 24
Total Progression free survival;Percentage of patients alive at 2 and 3 years;;Best overall response rate (BORR);;Duration of response (DoR);;Toxicity of the investigational medicinal products (IMPs).;Quality of life and general health;3 years PFS rate
Bayley Scales of Infant Development® - Third Edition (Bayley - III®);Pediatric Evaluation of Disability Inventory (PEDI)
Change from baseline in daily average pain intensity in index bone metastasis cancer pain site;Change from baseline in daily worst pain intensity in index bone metastasis cancer pain site;Change from baseline in weekly average pain intensity in non-index cancer pain sites;Change from baseline in weekly worst pain intensity in non-index cancer pain sites;Change from baseline in daily average pain intensity in non-index visceral cancer pain sites;Change from baseline in daily worst pain intensity in non-index visceral cancer pain sites;Change from baseline in Brief Pain Inventory (BPI) average pain score;Change from baseline in BPI worst pain score;Response as defined by a 30%, 50%, 70%, and 90% reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site;Change from baseline in Patient's Global Assessment of Cancer Pain;Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain;Change from baseline in the BPI Pain Interference with Function composite score and individual pain interference item scores;EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score;Average daily total opioid consumption (in mg of morphine equivalent doses);Average number of doses of rescue medication required per week;Change from baseline in weekly Opioid-Related Symptom Distress Scale;Adverse events;Standard safety assessments;Orthostatic (supine/standing) blood pressure assessment;Weight and Height measurements, Physical examinations.;Neurologic examination (Neuropathy Impairment Score [NIS]).;Survey of Autonomic Symptom scores;Anti-drug antibody (ADA) assessments;Joint safety adjudication outcomes;Total joint replacements
Discontinuation rate;Symptomatology;Psychosocial functioning;Cognitive function;MRI measures;Blood levels of bioactive lipids;Tolerability associated with omega-3 fatty acid treatment;Blood levels of (epi)genetic markers;Blood levels of immune parameters;Positive and negative symptoms;Level of functioning;Clinical Impression;Level of depression;Role functioning;Social functioning
Change From Baseline in Trough FEV1 at Day 42
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events;Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo
Safety and tolerability
Time to CV death;Time to all-cause death;Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation;Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death;Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke;Time to first occurrence of non-fatal myocardial infarction;Time to first occurrence of non-fatal stroke;Time to first occurrence of coronary revascularisation;Time to first occurrence of unstable angina requiring hospitalisation;Time to first occurrence of heart failure hospitalisation or urgent heart failure visit;Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%);Time to first occurrence of a 5-component composite nephropathy endpoint;Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%);Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%);Change in systolic blood pressure;Change in diastolic blood pressure;Change in pulse;Change in High sensitivity C-Reactive Protein (hsCRP);Change in total cholesterol;Change in high density lipoprotein (HDL) cholesterol;Change in low density lipoprotein (LDL) cholesterol;Change in triglycerides;Change in body weight;Change in waist circumference;Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire;Change in total score weight related sign and symptom measure;Change in haemoglobin A1c (HbA1c);Change in HbA1c
Delivery Rate and Live Birth Rate;Implantation Rate
Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
Fasting blood glucose (FBG);2-hours postprandial blood glucose;Hypoglycemia;Weight development;Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)
Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
Number of SBMs Per Week at Week 8;Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation;Number of SBMs Per Week at Week 12;Number of SBMs Per Week Overall
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP);Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI);Percentage of Participants Achieving ACR50
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Time to progression as measured by RECIST criteria;Comparison of toxicity levels (Grade III and IV);Comparison of quality of life before, during, after completion of study treatment;Impact of the treatment regimens on health economics
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Quality of Life
Change in Good ON Time From Baseline to Week 24;Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function;Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
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sponsor assessment of clinical response in the Bacteriologic per Protocol population;bacteriologic response for the remaining study populations;sponsor assessment of clinical response for the Bacteriologic per Protocol population;bacteriologic response for the Bacteriologic per Protocol population;summary of baseline susceptibilities;adverse events
OS, Contribution of the Components Analysis of Sub-study B;Percentage of Participants Alive at 12 Months (OS12);PFS, Contribution of the Components Analysis of Sub-study B;Objective Response Rate (ORR);Duration of Response (DoR);Percentage of Participants Alive and Progression Free at 6 Months (APF6);Percentage of Participants Alive and Progression Free at 12 Months (APF12);Time From Randomisation to Second Progression (PFS2) of Sub-study B
Number of Subjects With Treatment-related Adverse Events;Number of Subjects Developing Antibodies Against rIX-FP;Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis;Consumption of rIX-FP During Routine Prophylaxis
Rate of patients with clinical improvement;Time to first resolution of symptoms;Number of stools per week;Number of days with urgency per week;Rate of mucosal healing;Rate of histologic remission;Physician's global assessment at final visit;Quality of life
Change from baseline in DBP in the last six hours of the 24-hour dose period;Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period;Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59));Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.;Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).;Proportion of patients achieving a target response in SBP;Proportion of patients achieving SBP control;Proportion of patients achieving normal blood pressure;Proportion of patients achieving high-normal blood pressure;Change from baseline in trough seated SBP;Change from baseline in trough seated DBP;Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg
- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity
Measurement of lymphocyte depletion and recovery
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Time to death (all causes) or to worsening of PFTs up to End-of-Study.;Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline = 10% in FVC OR decrease from baseline = 15% in DLco AND = 6% in FVC
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LDL-cholesterol;HDL-cholesterol;VLDL-cholesterol;triglycerides;area under the triglyceride curve (AUC-TG);area under the VLDL-triglyceride curve (AUC-VLDL-TG);incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG);glucose;insulin;HOMA;HbA1c;interleukin-6;hs-CRP
pulmonary gas exchange, lung mechanics and ventilation/perfusion matching
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safety assessment
Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(?z), terminal half-life (t1/2 ?z).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].;Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).;Description of pharmacodynamics in terms of  total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.;Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.
Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone;Follicle size measured by transvaginal ultrasound examination;Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
Number of New or Newly Enlarging T2 Hyperintense Lesions;Number of Gadolinium-enhancing T1-weighted Lesions;Number of Subjects With Gadolinium (Gd)-Enhancing Lesions;Annualized Relapse Rate;Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Rate of failure
% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals;Biochemical Response at 3 Month Intervals;Symptom Control at 3 Month Intervals;Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study;Survival
Longer-term Safety of VIVITROL
Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration);Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration);Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration);Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)
MACE;MACE;MACE;Binary restenosis rate
Change in Number of Micturitions;Change in Number of Nocturia Episodes;Maximum Cystometric Capacity (MCC) by Urodynamic Measurements;Incontinence Quality of Life Instrument (I-QOL)
Overall survival (interval between date of randomization and death from any cause;Response rate (proportion of subjects who achieve complete, partial, or minimal response)
Change from baseline in blood test for kidney function after 30 weeks;Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg;Change from baseline in circulating marker of inflammation after 30 weeks
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment;Duration of Treatment;Treatment Compliance by Visit
Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.;Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.;Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.;Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.;Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).;Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.;Further possible prognostic factors will be evaluated.;Safety variables will be summarized using descriptive statistics based on adverse events collection.
Endometriosis-associated pain;Endometriosis-associated pain;Endometriosis-associated pain;Endometriosis-associated pain
First Occurrence of Stroke;Death From Any Cause;First Occurrence of Any Heart Failure (HF) Episode;First Hospitalisation for Heart Failure (HF);First Hospitalisation for Other Cardiovascular (CV) Cause
Percentage of Participants With Mucosal Healing at Week 52;Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline;Percentage of Participants in Remission at Week 24;Percentage of Participants in Sustained Remission;Percentage of Participants With Mucosal Healing at Week 24;Percentage of Participants With Sustained Mucosal Healing;Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Clinical Response at Week 24 and 52;Percentage of Participants With Sustained Clinical Response;Percentage of Participants in Clinical Remission at Week 24 and 52;Percentage of Participants in Sustained Clinical Remission;Percentage of Participants in Deep Remission at Week 24 and 52;Percentage of Participants in Sustained Deep Remission;Percentage of Participants in Symptomatic Remission at Week 24 and 52;Percentage of Participants in Sustained Symptomatic Remission;Percentage of Participants in Endoscopic Remission at Week 24 and 52;Percentage of Participants in Sustained Endoscopic Remission;Total Mayo Score at Baseline, Week 24 and 52;Change From Baseline in Total Mayo Score at Week 24 and 52;Percentage of Participants in Remission, Among Participants With Remission at Baseline;Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline;Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline;Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline;Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
All-cause mortality;Cardiovascular mortality;Non-Fatal Heart Failure Events;6-minute walking distance;Quality of Life questionnaires;Unplanned Hospitalization;Ventricular arrhythmias requiring device therapy
progression-free survival
Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1);Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1);Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1);Changes in size of LDL subfractions compared with screening (visit 1)
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck;Change From Baseline to the EAP in Mean Serum Phosphorus;Change From Baseline to Week 52 in eGFR;Change From Baseline to the EAP in Corrected Total Calcium;Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH);Change From Baseline to the EAP in Urine Phosphorus;Percentage of Participants With a Parathyroidectomy;Time to Parathyroidectomy
Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period
Assessment of the safety and tolerability by adverse event documentation.;Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I).;Correlation between dosage, efficacy and adverse events.;Ziprasidone serum levels;Correlation between serum level, efficacy and adverse events
Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures
Incidence of myelosuppression (ANC < 500/ul for > 2 days, platelets < 20,000/ul for > 2 days) after initial PBSC infusion;Response of malignancy to DLI;Incidence of aplasia after DLI;Dose of CD3+ cells required to convert mixed to full lymphoid chimeras;Incidence of non-relapse mortality
Positive antibodies to bezlotoxumab;Infusion-related reactions;CDI recurrence and sustained clinical response;Sustained clinical response;Clostridium difficile infection (CDI) recurrence
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level;Overall Survival Using Kaplan-Meier Methodology;Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase);Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d);Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d);Maximum Concentration of Serum Testosterone [Cmax] - Raw Data;Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data;Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL;Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1
Number of Participants Experiencing An Adverse Event;Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16;Change From Baseline in Tender Joint Count at Week 16;Change From Baseline in Swollen Joint Count at Week 16;Change From Baseline in Participant's Assessment of Joint Pain at Week 16;Change From Baseline in Participant's Assessment of Disease Activity at Week 16;Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16;Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16;Percent Change From Baseline in C-reactive Protein (CRP) at Week 16;Change From Baseline in Disease Activity Score (DAS28) at Week 16;Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16;Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16;Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16;Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes;Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16;Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state;Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)
Incidence of Loco-regional relapse;Disease-free survival;Progression-free survival;Overall survival;The rate of patients with secondary primary neoplasm;The incidence of late toxicity
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Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment
Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24);Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable;Percentage of Participants With On-treatment Failure;Percentage of Participants With Viral Breakthrough;Percentage of Participants With Viral Relapse;Percentage of Participants With Normalized Alanine Aminotransferase Levels;Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure;Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load;Mean Change From Baseline in CD4+ Cell Count;Change From Baseline in CD4+ Cell Count in Percentage;Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed);Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis;Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis;Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216;Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168;Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432;Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline;Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions;Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
Proportion of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)];Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)];Duration of Response (DoR);Time to First Response (TTR);Progression Free Survival (PFS);Overall Survival (OS);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.;Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants With Gastric and/or Duodenal Erosions.
Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6;Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein;Left ventricular ejection fraction as assessed by echocardiography;Exercise testing using spiroergometry
The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate
MMR Rate;<10% BCR-ABL^IS Rate;Complete Cytogenetic Response (CCyR) Rate;Progression-free Survival;Overall Survival
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Rate of R0 liver resection (ITT- population);Progression free survival (ITT- population);Disease free survival after resection (ITT- population);Overall survival (ITT- population);Safety (all patients that received any study drug);Molecular predictive markers for response and toxicity
Biomarkers in PXE
blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms
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Number of stools per week;Number of bloody stools per week;Time to first resolution of clinical symptoms
Overall survival at 2 months after treatment;Progression-free survival at 2 months after treatment;Remission quality at 2 months after treatment
Changes in glucose, insulin and NEFA concentrations.
All-cause mortality;Ventilator-free days;ICU-free days;Hospital-free days;Sepsis-related Organ Failure Assessment (SOFA) score;Modified Denver score;Composite endpoint of Time to Complete Organ Failure Resolution (CTCOFR)
Number of Patients with Adverse Events and Serious Adverse Events;Objective response rate (ORR);Early progression rate (EPR);Plasma pharmacokinetics (PK) parameters
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Percentage of Participants With Radiographic Evidence of Healing;Percentage of Participants With Pain Control During Ambulation;Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit;Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing;Percentage of Participants With Functional Evidence of Healing;Percentage of Participants Able to Ambulate;Percentage of Participants Who Regained Their Prefracture Ambulatory Status;Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain;Mean Change From Baseline to 6 Months in Gait Speed;Time to Revision Surgery;Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores;Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC);Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score
Time to progression;Safety and tolerability;Overall survival
Progression free survival;Objective response rate;Time to disease progression;Disease control rate;Number of subjects with adverse events
Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.;Change in endurance capacity;Change in body composition;Change in quality of life;Change in depression;Time of the first tumor progression under TKI therapy;Time of reduction or replacement of TKI therapy
DINAMO TM: Change from baseline in fasting plasma glucose (mg/dl);DINAMO TM: Change from baseline in body weight (kg);DINAMO TM: Change from baseline in systolic blood pressure (SBP);DINAMO TM: Change from baseline in diastolic blood pressure (DBP);DINAMO TM: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM: Proportion of patients who achieve HbA1c < 7.0%;DINAMO TM Mono: Time to treatment failure;DINAMO TM Mono: Change in HbA1c (%) from baseline;DINAMO TM Mono: Change in FPG (mg/dL) from baseline;DINAMO TM Mono: Change in body weight (kg) from baseline;DINAMO TM Mono: Change in SBP (mmHg) from baseline;DINAMO TM Mono: Change in DBP (mmHg) from baseline;DINAMO TM Mono: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM Mono :Proportion of patients who achieve HbA1c < 7.0%
• Change of crestal bone level;• Soft tissue parameters
Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.;Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results
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Progression-free Survival (PFS) as of 19 October 2015;Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) as of 19 October 2015;Disease Control Rate (DCR) as of 19 October 2015;Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015;Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015;Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015;Participants With Treatment-Emergent Adverse Events as of 23 December 2015;Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey;Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test
Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14;Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22;Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI);Number of Participants With Abnormal Electrocardiogram (ECG) of PCI;Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI;Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X;Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086;Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086;Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis
Postoperative Myalgia
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria;Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%;Radiographic Progression-free Survival
Average Consumption of N8-GP During Surgery;Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6;Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14;Average Consumption of N8-GP During the Post-operative Period Days 1-6;Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL);Estimated Blood Loss During Surgery;Number of Transfusions During the Post-operative Period Days 1-6;Length of Stay in the Hospital;Number of Days in Intensive Care;Adverse Events Reported During the Trial Period;Serious Adverse Events Reported During the Trial Period
Overall survival within at least the first 5 years after treatment;Loco-regional failure, defined as local or regional recurrence, inoperable disease, or R1 or R2 resection;Distant failure (i.e., distant metastasis);Pathological down-stage (ypT0, 2N0) rate;Pathological complete remission (ypT0N0) rate;Tumor regression grade;Histopathological R0 resection rate;Sphincter preservation rate;Preoperative complication rate;Toxicity according to CTCAE v.3.0 weekly during treatment, at 4-8 weeks after surgery, at therapy completion, and every 6 months for 5 years after therapy completion;Overall survival within at least the first 5 years after treatment;Loco-regional failure, defined as local or regional recurrence, inoperable disease, or R1 or R2 resection;Distant failure (i.e., distant metastasis);Pathological down-stage (ypT0, 2N0) rate;Pathological complete remission (ypT0N0) rate;Tumor regression grade;Histopathological R0 resection rate;Sphincter preservation rate;Preoperative complication rate;Toxicity according to CTCAE v.3.0 weekly during treatment, at 4-8 weeks after surgery, at therapy completion, and every 6 months for 5 years after therapy completion
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Rate of endoscopic remission/improvement at final/withdrawal visit;Number of stools / bloody stools per week
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML);Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase;Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD);Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS);Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2;Half Life of Panobinostat After the First Dose in Arms 1 and 2;Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15;Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15;Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X;Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y;Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week);Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
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The mean endpoint (week 10) sleep interference score change from baseline;Analysis of the Medical Outcomes Study Sleep Scale;Analysis of the Patient Global Impression of Change;Analysis of the Neuropathic Pain Symptom Inventory
Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks;Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab;Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS);Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Pain;Change in prostate specific antigen;Quality of Life;Correlation between pain and bone turnover;Correlation between bone complications and bone turnover
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Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.;Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires.;Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests.;Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.
Biomarkers in PXE
- AF/AFL related symptoms collected at the time of ECG/TTEM recording,;- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM);- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
differences in counterregulatory hormonal response to physical stress
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Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose;Percentage of Participants With Hypoglycemia;Nadir Glucose;Time to the Nadir Glucose;Duration of Glucose =70 mg/dL;Fasting Blood Glucose;Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC);Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion;Beta Cell Function
Patients' Global Impression of Change Scale;Spinal cord injury classification;Spinal Cord Independence Measure;Perceived exertion;Spasticity;Walking Index for Spinal Cord Injury (WISCI);Patients' Global Impression of Change Scale;Spinal cord injury classification;Spinal Cord Independence Measure;Perceived exertion;Spasticity;Walking Index for Spinal Cord Injury (WISCI)
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods;Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL);Change in hemoglobin level;Number of patients with hemoglobin levels outside the target range;Dose level in the evaluation period;Duration of exposure on each dose level;Number of subjects requiring titration of dose;Number of participants with serious adverse events as a measure of safety and tolerability
Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs);Insulin-like Growth Factor-I (IGF-I) Levels;Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels;Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS);Treatment Adherence Rate as Documented Using EasypodTM Connect
Percentage Of Participants With Breakthrough Hemolysis (BTH);Percent Change From Baseline In Lactate Dehydrogenase (LDH) Levels;Change From Baseline In Quality Of Life As Assessed By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue;Percentage Of Participants With Stabilized Hemoglobin Levels
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Rate of adverse events;Severity of adverse events;Safety laboratory parameters;Vital signs;Electrocardiogram;Physical exam
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan;Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS);Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT);Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period;Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug
Disease-free survival;Quality of Life for pts in the RICT and Control Groups.;Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts;Acute and Chronic Graft-versus-Host Disease (GvHD)
Inflammageing status as measure of ageing-associated inflammatory processes;Oxidative stress;Gut micobiota;Quality of life (QoL);Physical performance status;Compliance
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Fatigue;Quality of Life;Hemoglobin, Leukocytes, Thrombocytes;Side-effects (Infections, GvHD, Depression, Distress);Adherence to exercise protocol;Muscular strength;cardiorespiratory fitness;IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin;median survival, non-relapse mortality
Serum PK of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 1 x 300mg/d tobramycin nebulized solution (= TNS) inhaled with the PARI eFlow rapid in cystic fibrosis subjects.;Compare serum PK of inhaled tobramycin (trough-/peak-level)of both dosing regimens in CF-subjects with a FEV1=80% vs. CF-Subjects with a FEV1<80%.;Change of MIC of P. aeruginosa during a continuous treatment with 1 x 300 mg/d and 2 x 300 mg/d TNS.;Assess safety of a continuous daily dosing regimen with 1 x 300 mg/d and 2 x 300 mg/d TNS over 8 weeks, compared to historic safety data of the 4 week on/off dosing regimen with 2 x 300 mg/d.
Blood loss and transfusion rate
Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.;Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline;Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline
Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids;Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose
Total pain relief 6, 72, 96 and 120 hours after first dosing;Pain intensity relief over initial 6 hours;Pain intensity difference after 48, 72, 96 and 120 hours after first dosing;Overall efficacy after 48, 72, 96 and 120 hours after first dosing;Total dose used over 5 days;Time till use of rescue medication;Safety - assessment of adverse events
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acute toxicity;local recurrence free survival;overall survival;quality of life
Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed;Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt;12-lead electrocardiograph (ECG) measurements;Number and frequency of adverse events (AEs);Clinical laboratory data;Vital sign measurements
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To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.;To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.
Serum Tobramycin Concentrations;Percentage of Participants With a Decrease From Baseline in Auditory Acuity;Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1);Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication;Change From Baseline in Pseudomonas Aeruginosa Sputum Density;Change From Baseline in Tobramycin Minimum Inhibitory Concentration;Antipseudomonal Antibiotic Usage During the Study;Hospitalization Due to Respiratory Events During the Study
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine);Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).;Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).;Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).
HADS depression score;Quality of life (SF-12);Prevalence of Type D personality among ICD patients;Frequency of contacts between patient and physician;Patient's perception of ICD therapy;Patient mobility
Neurological status (motor function, sensor function) of ischemic limb;Systemic complications in both therapy groups;Tolerance of reperfusion solution;Lethality
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Area under the insulin degludec concentration-time curve from 0-24 hours at steady state
Change in PGA (Physician Global Assessment) scores from baseline to Week 12;Change in Patient Psoriasis Global Assessment scores from baseline to Week 12;Change in affected Body Surface Area (BSA) from baseline to Week 12;Measurement of improvement in the PASI (50) from baseline at Week 12
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
Pharmacokinetic profile of CGM097;Tumor response per RECIST;Pharmacodynamic effect of CGM097;Changes in laboratory values, vital signs or cardiac functionality, dose reduction, dose interruption and dose intensity, incidence and severity of adverse events.
Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.;Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64;Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64;Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64;Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64;Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64;Change From Baseline in Percent HbA1c at Week 52;Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64);Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64;Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52;Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52;Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Change From Baseline in Body Weight (Kilograms) at Week 52;Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64);Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F];Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F];Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]
Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel;Plasma Clearance (CL) for Cabazitaxel;Percentage of Participants With Treatment-emergent Adverse Events (TEAEs);Time to First Definitive Consumption of Narcotic Medication;Time to Definitive Weight Loss by 5% and 10% From Baseline;Time to Definitive Deterioration of ECOG PS Score From Baseline;Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales;Percentage of Participants With FACT-P Total Score Response;Change From Baseline in FACT-P:Total Score as a Measure of HRQoL;Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL);Percentage of Participants With Pain Response;Time to Pain Progression;Percentage of Participants With PSA Response;Time to PSA Progression;Percentage of Participants With Overall Objective Tumor Response;Time to Tumor Progression;Progression Free Survival (PFS)
Safety and efficacy endpoints;Procedural complications;Protocol adherence;Per protocol analysis
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1. Amount of Slow wave Sleep;2. sleep spindels;3. EEG-correlates;4. further memory systems
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.;O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
Clinical Device Success;Clinical Procedure Success;Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable, Possible);Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;In-segment Late Loss (LL);In-stent Angiographic Binary Restenosis Rates;In-segment Angiographic Binary Restenosis Rates;In-stent Percent Diameter Stenosis;In-segment Percent Diameter Stenosis;Adjudicated Revascularization (TLR/TVR/All Revascularizations);Adjudicated Revascularization (TLR/TVR/All Revascularizations);Adjudicated Revascularization (TLR/TVR/All Revascularizations);Aneurysm;Thrombus;Persisting Dissection
Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.
Occurence of major adverse events;Technical success defined as successful insertion and deployment of the device in the intended location .;Successful aneurysm repair defined as absence of Type I or III endoleak and absence of aneurysm enlargement confirmed on imaging.;Absence of stent graft migration (> 10 mm);Absence of stent graft fracture;Absence of aneurysm sac rupture;Amount of time it takes to complete the procedure;Amount of time fluoroscopy is used during the procedure;Amount of contrast volume used during the procedure
Adverse events;Laboratory abnormalities
Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration;Clinical/demographic patients characteristics at initiation of treatment;Safety: Incidence of adverse events;Patient reported outcome: Quality of life (FACT B questionnaire)
Tolerability;Overall survival;Best Overall Response Rate;Overall response rate;Overall Response Rate;Best Overall Response Rate;Response rate of injected metastases only;Rate of patients with substantial increase of anti-melanoma T-cells in peripheral blood during treatment;Changes in T-cell subsets during treatment;Changes in subsets of tumor-infiltrating lymphocytes during treatment
To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.;To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma;To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue;To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.;To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
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Total mortality;sudden cardiac death;Cardiovascular mortality
Investigation of the use of the tonsils, as the only available secondary lymphoid organ, for the determination of the immune status of patients with sepsis
Overall survival within 4 years.
Exploratory data analysis of the following parameters: <br>- Height of the coronary arteries,  sinus of valsalva diameter, sinutubular junction diameter, <br>(the measurement of these parameters using CT and TEE are performed before intervention).<br>- angulation angle (the angle is measured by using CT before intervention and by fusion periinterventionally).
Proportion of patients in whom coronary angiography (CA) is performed Copeptin vs. Control arm.;Rate of ALL major adverse cardiac events (MACE);Patient satisfaction regarding management within the ED/CPU;Length of hospital stay
Possible, respectively missed indications for pre-hospital TXA application
At the second assessment point, the nursing staff will evaluate the acceptance and applicability of the intervention using a self-developed questionnaire
Derivation of diagnostic parameters. Comparison of derived parameters with established methods.
morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month.<br>mortality: number of death during the observation period of 9 month.<br>Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)
radiological proof of a change in the calcification in the postoperative x-ray
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Colour stability, soft tissue reaction, clinical handling, accuracy of fit, outer shape, plaque accumulation, adhesion to the tooth stump and patients' opinion of the temporary restorations being made of Protemp 4 in comparison to the data of the  temporary restorations being made of Luxatemp® Automix Plus (Reference data)
Reduction of on demand medication during follow-up (day 4-7). On demand opioid drug use will be converted into an oral morphine equivalent (OME) for ease of comparison (Baseline, Therapy, Follow-up).
Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure
Current antiretroviral therapy, remaining options. Virological and immunological situation. Physical and mental health of the patients. Adherence and treatment satisfaction with current antiretroviral therapy (evaluated by questionnaires)
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same as primary end point but in relation to German average
Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline<br>- - - Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline (visual acuity measured by ETDRS-charts)<br>- - - Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 (at month 2)<br>- - - Drop out rates<br>- - - Rate of non-responders<br>- - - Retinal lesions <br>- - - Changes in retinal thickness from baseline at month 4 and 12 (visit 13) via Optical Coherence Tomography (OCT)<br>- - - AEs<br>- - - Quality of Life at visit 1 (before treatment) and visit 13 (month 12); questionnaire VFQ25.
Prescribing and reporting behavior of outpatient doctors
Not applicable
Mortality
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Number of Participants Who Experienced an Adverse Event (AE);Number of Participants Who Discontinued Study Drug Due to an AE;Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants;Overall Survival (OS) Rate at Month 12 in All Participants;Overall Survival (OS) Rate at Month 18 in All Participants;Overall Survival (OS) Rate at Month 24 in All Participants;Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score;Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
Quantitative strength measurement (QSM, M3diagnos, Fa. Schnell, Germany), Neuromuscular Symptoms Score (NSS), timed function tests, Clinical Global Impressions (CGI) of change and quality of life assessment(SF-36 scale).
Speed of analysis
isoflavone metabolites in body fluids
4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:<br>•Influence of patellar stabilization on patellofemoral kinematics, determined using MRI at 0,10,20,30° of flexion<br>•Measure of cartilage compression,determined using MRI at 0,10,20,30° of flexion<br>•Measure of cartialge relaxation times,determined using MRI at 0,10,20,30° of flexion
progression-free survival rate at 9 and 12 months;median progression-free survival;response rate;duration of response;toxicity;tolerability;overall survival;time to treatment failure;evaluation of the predictive and prognostic relevance of biomarkers
mechanisms of change of the training, measured by qualitative interviews with the trainers, the team and the team members. Analyzed by qualitative content analysis.
• Diagnostic performance regarding flat and papillary tumours<br>• False-positive rate<br>• To evaluate systemic absorption and pharmacokinetics (PK) of<br>Hypericin after a single intravesical instillation of PVP-Hypericin in a<br>sub-group of patients (N=15-20)<br>• To assess the safety of PVP-Hypericin (data collection of adverse events)
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secondary endpoint: inflammatory parameters and mediators in the blood)
At time point six months post training period<br>-  TAP (Testbatterie für Aufmerksamkeit, test battery for attention) <br>-  Berg Balance Test (BBT)<br>-  Activity of Daily living (ADL) and Instrumental activity of daily living (IADL)<br>-  Functional gait category (FAC)<br>-  6min walking test (6mintest)<br><br>At the end of the training period<br>- amount of total steps during the training period
- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes)<br>- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation. <br>- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above
subjective rating together with speech intelligibility (using questionnaire HisQui19)
Neurological outcome;Health Status;Infarct volume;Successful Recanalization
Expiratory peak flow, measured by pneumotachography as mean for the duration of the experiment. Regional ventilation, measured by electrical impedance tomography as a mean for the duration of the experiment. Subjective perception, rated by the volunteer as forced choice (better/worse), directly after the experiment.
Operative morbidity and mortality
Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition analyzed
Diagnostic performance of QFR in comparison to FFR;QFR- FFR diagnostic grey zone calculation.;Diagnostic performance of iFR in comparison to FFR;iFR- FFR diagnostic grey zone calculation.;effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.;Effect of lesion location on QFR-iFR-FFR disagreement.;Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.
Pain during wound dressing after tumor excision with visual analog pain scale (VAS)<br>scar quaulity (POSAS scar scale) 6-12 months after skin grafting
strength (MRC, grip strength), fitness (PFIT-s), ADL (Barthel-Index) directly before study therapy, directly after last study therapy unit and 3 weeks after the last examination<br><br>time till achiving indipendent sit to stand from a normal chair: daily measurement before start of study therapy until discharge
Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1
Secondary endpoint are cognition, assessed by the Trail Making Test, walking performance in single-task and dual-task condition (counting backwards in steps of 3), assessed on a GAITRite mat,and the sit-to-stand performance, classified by the time needed, during exposure to 15°C and 25°C environment, each.
Translational research program;Quality of life (EORTC QLQ-C30);Safety - side effects;Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria)
Secondary outcome are total cortisol output i.e. AUCi
Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly
Blood or plasma cortisol during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) at baseline and at the post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.
- participation rate<br>- number of complications arising in the screening colonoscopies in the program<br>- positive predictive value of iFOBT (immunological fecal occult blood test): frequency of true and false positive findings
Hormone Assays: Luteinizing Hormone (LH).;Hormone Assays: Follicle-stimulating Hormone (FSH).;Hormone Assays: Testosterone.;PK: Mean Clearance.;PK: Mean Volume of Distribution (V1/F);PK: Mean Volume of Distribution (V2/F) .;Change in Breast Tanner Stage From Baseline to Month 12.;Change in Pubic Tanner Stage From Baseline to Month 12.;Change in Predicted Adult Height (PAH) From Baseline to Month 12.;Percentage of Patients With Gsa Mutation.;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced =50% Reduction in the Number of Vaginal Bleeding Days;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .;Change in Bone Age Advancement Over the First 6 Month Trial Period.;Change in Bone Age Advancement Over the Second 6 Month Trial Period.;Change in Bone Age Advancement Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.;Change in Uterine Volume From Baseline to Month 12 by Ultrasound.;Change in Uterine Volume From Baseline to Month 6 by Ultrasound.;Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.;Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.;Hormone Assays: Serum Oestradiol.
Overall Survival (OS);3 and 5 year survival probabilities;Objective Response Rate (OR: CR or PRR);Duration of Response (DOR);Clinical Benefit Rate (CBR: CR or PR or SD = 24 weeks;Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0);Patient Reported Outcomes
Overall survival;Quality of life;Response rate;Molecular investigations
Molecular complete remission rate (CR);Hematologic complete remission rate;Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3
Recurrence;Global Cure
Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.
Number of subjects reporting each solicited local adverse event (AE).;Number of subjects reporting each solicited general AE.;Number of subjects reporting any unsolicited adverse event (AE).;Number of subjects reporting any potential immune-mediated diseases (pIMDs).;Number of subjects with serious adverse events (SAEs).;Rate of moderate and severe AECOPD in vaccinated and control subjects;Rate of all AECOPD cases in vaccinated and control subjects;Rate of all AECOPD cases, classified by severity.;Time to first moderate or severe AECOPD.;Time to first AECOPD of any severity.;Time to first AECOPD classified by severity.;Number of days with moderate and severe AECOPDs.;Number of days with AECOPDs of any severity.;Number of days with AECOPDs classified by severity.;Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD.;Rate of NTHi-associated and/ or Mcat-associated any severity AECOPD.;Rate of NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity.;Time to first moderate and severe NTHi-associated and/ or Mcat-associated AECOPD.;Time to first NTHi-associated and/or Mcat-associated AECOPD of any severity.;Time to first NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD.;Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity.;Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Anti-PD, anti-PE, anti-PilA and anti-UspA2 total Immunoglobulin G (IgG) antibody concentrations as measured by the Ezyme-Linked Immunosorbent Assay (ELISA,) in all subjects.;Frequency of specific cluster of differentiation (CD)4+ T-cells immune response for NTHi-specific and Mcat- specific measured by flow cytometry intracellular cytokine staining (ICS) in a sub-cohort of subjects.
Change in local laboratory hemoglobin level from baseline;Speed of change in hemoglobin level per unit time;Duration of treatment exposure;Number of participants with serious adverse events as a measure of safety and tolerability;Pharmacodynamics characterized by erythropoietin concentration;Pharmacodynamics characterized by reticulocyte count
1. To investigate duration of PFS as well as the influence of changes in individual SUV and of early clinical response on PFS<br>2. To investigate duration of overall survival (OS)<br>3. The assessment of antivascular/antiangiogenic effects of cetuximab by contrast-enhanced ultrasound<br><br>This clinical trial will include an accompanying research component involving collection of biological samples for pseudonymised analyses. These will comprise sequential serum protein marker assessments (e.g., multiplex cytokine immune monitoring) as well as baseline analysis of tumour proteins and tumour genes, (e.g., PTEN expression, mutations in EGFR dependent downstream kinases like PI-3-kinase, BRAF and EGFR gene expression as measured by fluorescence-in-situ hybridisation). Patients may participate in this study even if they choose not to participate in this component.
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Change from Baseline Mean Systolic Blood Pressure (SBP) at the last week of each treatment phase;Change from Baseline Blood Pressure Variability (BPv) at the last week of each treatment phase
Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16
Percentage of Participants With Major Molecular Response (MMR) at Year 1;Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks;Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks
Secondary end point(s): •Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner.<br>•Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.<br>•Safety and tolerability through assessment of AEs and changes in safety assessments and laboratory parameters.<br>•Disease control as measured by the percentage of patients whose best response was not progressive disease (PD) (ie, complete response [CR], partial response [PR], or stable disease [SD] per RECIST v1.1).  Stable disease will be included if it occurs at least 6 weeks after randomization.<br>;Timepoint(s) of evaluation of this end point: Secondary efficacy analysis will be conducted for the intent-to-treat population. <br>Progression-free survival will be determined from the randomization date until the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause if earlier.
Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).
Phase 1 and Phase 2: Number of Participants With any Treatment-emergent (TE) Serious Adverse Event (SAE);Phase 1 and Phase 2: Number of Participants With any TEAE;Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, AUC: Area Under the Plasma Concentration-time Curve of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 2, CL: Model Predicted Apparent Total Body Clearance of Eribulin;Phase 2, Vd: Model Predicted Apparent Total Body Volume of Distribution of Eribulin;Phase 2: Progression-free survival (PFS);Phase 2: The Clinical Benefit Rate (CBR)
<br>                1. Other toxicity endpoints including but not limited to: fibrosis, induration and vascular changes (breast); rectal incontinence, urinary toxicity and erectile dysfunction (prostate); dysphagia and oesophagitis (lung)<br>                2. Quality of life<br>                3. Maximum grade of toxicity during follow-up period<br><br>                Toxicity will be assessed and documented using REQUITE toxicity questionnaires based on the CTCAE v4.0 and EORTC Quality of Life at the following time points.<br>                1. Baseline assessed prior to radiotherapy (all)<br>                2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients<br>                3. 3 months from start of radiotherapy (lung)<br>                4. 6 months from start of radiotherapy (lung)<br>                5. 12 months from start of radiotherapy (all)<br>                6. 24 months from start of radiotherapy (all)<br>
1. Adverse birth outcomes are measured using<br>1.1. Mortality defined as intra-uterine death or death before hospital discharge<br>1.2. Acidosis defined as arterial cord blood pH<7.15<br>1.3. Apgar at 5 minutes <7 <br>1.4. Admission to NICU<br>1.5. Operative delivery for fetal distress (fetal scalp blood analysis pH < 7.20 or abnormal fetal heart rate tracing<br>2. Abnormal child growth pattern are measured using patient records (as defined below the 10th percentile of normal population) during first year of life<br>3. Abnormal metabolic profile (umbilical cord blood) at birth in comparision to the control group<br>4. Abnormal cardiovascular outcomes are measured using aortic intima media thickness >75th centile and/or BP > 95th centile at birth and at 12 months of age<br>5. Prediction of mean blood pressure (BP) at one year of age (mm Hg) using the following measurements: metabolic profile, fetal functional echocardiographic parameters others than the ones used for primary outcome <br>6. Correlation of mean blood pressure (BP) at one year of age (mm Hg) and autonomic nervous system [average acceleration and deceleration capacity (bpm)] and antenatal/ fetal functional echocardiographic parameters<br>7. Correlation of antepartal cardiac function parameters and those at 1 year of life<br><br><br>
Immunogenicity pre and post-booster and safety (follow up of SAEs);Immunogenicity pre and post-booster and safety (follow up of SAEs)
MCyR at Any Time Prior to Crossover;Duration of MCyR at 12 Months and 18 Months;Duration of MCyR at 24 Months;Time to MCyR Prior to Crossover;Complete Hematologic Response (CHR) at Any Time Prior to Crossover;Duration of Complete Hematologic Response (CHR);Time to CHR Prior to Crossover;Major Molecular Response (MMR);CHR After Crossover;Cytogenetic Response After Crossover;Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover;Health-Related Quality of Life Prior to Crossover;Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib
Not provided at time of registration
Change from Baseline in Hb Concentration at Weeks 16, 20 and 24 in Part 2;Maximum Change from Baseline in Hb Concentration;Time to Achieve an Increase in Hb Concentration of 1.5 g/dL or More;Change from Baseline in Bilirubin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Lactic Acid Dehydrogenase (LDH) at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Haptoglobin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Reticulocyte Percentages at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Pyruvate Kinase Deficiency Diary (PKDD) Score;Change from Baseline in Pyruvate Kinase Deficiency Impact Assessment (PKDIA) Score;Percentage of Participants Experiencing an Adverse Event;Percentage of Participants Experiencing an Adverse Event of Special Interest (AESI);Change from Baseline in Bone Mineral Density Z-Score at Week 24 in Part 2;Change from Baseline in Bone Mineral Density T-Score at Week 24 in Part 2;Area Under the Curve From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] for AG-348 at Week 12;Maximum Plasma Concentration (Cmax) for AG-348;Time to Cmax (Tmax) for AG-348;Time to Last Measurable Concentration (Tlast) for AG-348
Difference between the neuropsychological testing of attention (Test of attentional performance) after placebo and after medication (LTG and LOV);Differences in short interval cortical inhibition (SICI) after placebo and after medication (LTG and LOV)
American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;Simplified Disease Activity Index (SDAI) =3.3 (remission);Proportion of subjects with Disease Activity Score 28-joint count (DAS28) low disease activity;Changes in DAS28 (CRP);Changes in Health Assessment Questionnaire-Disability Index (HAQ-DI);Improvement in HAQ-DI;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in SDAI and Clinical Disease Activity Index (CDAI);Responses for European League Against Rheumatism (EULAR) based on DAS28 (CRP);Changes in components of American College of Rheumatology (ACR) Criteria;Impact of ADAs to OKZ on subject safety and efficacy;Impact of ADAs to OKZ on subject safety and efficacy
to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS);to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization;Overall survival from second randomization;Complete Response (CR) rates after induction therapy;Complete Response (CR) after high dose therapy;Complete Response (CR) during/after maintenance therapy;MRD negativity after high dose therapy;MRD negativity during and after maintenance therapy;Best response to treatment during the trial;PFS 2 (PFS after next line of therapy) from 2. randomization;Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events;Quality of Life Assessment;Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only);Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only)
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<br>                1. Global Assessment Scale (GAS)<br>                2. UKU side effects rating scale<br>                3. Antidepressant side effect scale<br>                4. Client Service Receipt Inventory (CSRI)<br>                5. Temperament and Character Inventory - Revised (TCI-R)<br>                6. Brief Life Events Questionnaire (BLEQ)<br>                7. Sexual Functioning Questionnaire (SFQ)<br><br>                Secondary analyses will include analysis of baseline data, and data up to week 12 and up to week 26. As there are many measures in this study and many time points, it is not possible to prestate all the secondary analyses that will be performed.<br>
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Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC);Change from Baseline on Mini-Mental Status Examination (MMSE);Change in expected decline of whole brain volume as measured by brain MRI
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77;Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77;Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77;Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77;Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77;Number of Any Adjudicated Bleeding Events at Days 47 and 77
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data;Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data
1. Global Assessment of Functioning Scale (GAF): the GAF is a brief scale of overall functioning of demonstrated reliability and validity that is used in routine clinical practice and in recent trials in bipolar disorder. The GAF will be used to provide an overall estimate of functioning during the previous year.<br>2. Deliberate self-harm: deliberate self-harm of suicidal intent (including suicide) is a common outcome in bipolar disorder and of obvious clinical importance. There is observational evidence that lithium therapy reduces the incidence of suicide and it is important to measure this outcome, although it is unlikely that BALANCE will have sufficient power to detect a treatment effect reliably.<br>3. Quality of life: the EuroQol (EQ-5D) will be used to assess quality of life. This questionnaire has been used successfully in two contemporary trials in psychiatry - the ongoing NHS R&D CUtLASS trial of atypical antipsychotics and the recent MRC-funded trial of cognitive behaviour therapy in bipolar disorder.<br>4. Adverse events: patients have identified adverse events and side-effects as being one of the main negative aspects of long term medication. Valproate semisodium is a newly licensed drug in the UK and it is essential to record the occurrence of all adverse events.<br>5. Withdrawal from study treatment: withdrawal from allocated treatment is a useful and pragmatic, although non-specific, measure of the overall acceptability and efficacy of a drug<br>6. Adherence to study medication: adherence to maintenance treatment is frequently overlooked in maintenance trials in bipolar disorder but is essential for interpreting the trial results
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Modelling of solute kinetics
1. Frequency of alcohol and drug abuse in patients undergoing femoral neck repair, examined directly after inclusion of the patient in the study<br>2. Peri-operative incidence of pulmonary, renal and cardiovascular dysfunction and of protocol violations, examined the whole time during the hospital stay of the patient <br>3. Post-operative incidence of infections, examined the whole time during the hospital stay of the patient<br>4. Quality of life (measured using the EuroQoL instrument), examined after inclusion in the study and 90 days after the operation
Overall survival (OS);Incidence of adverse events and significant laboratory abnormalities;Pharmacokinetics of AMG 386 (Cmax and Cmin);Incidence of anti-AMG 386 antibody formation;Patient reported ovarian cancer-specific symptoms and health related quality of life;Patient reported status as measured by the EuroQOL (EQ-5D);AMG 386 exposure-response relationships for PFS and OS;Correlation of serum biomarkers with measures of response
Timepoint(s) of evaluation of this end point: 12 weeks;Secondary end point(s): The secondary efficacy endpoints include the following:<br>• % change in HDL C, TC, and Apo B from baseline to Week 12<br>• % change in Apo A1 and Apo A2 from baseline to Week 12<br>• % change in LDL C, small LDL particles (small and dense LDL), VLDL C (calculated as TC - LDL-C - HDL-C), Apo B48, Apo C2, Apo C3, adiponectin, FGF21, hsCRP, LCAT, CETP mass and activity, PCSK9 mass, HDL function (reverse cholesterol transport, HDL driven endothelial production of nitric oxide, Ion mobility analysis, 2 D gel analysis for HDL sub fractions including pre beta HDL, Calculation: TC/HDL C, non HDL C/HDL C, Apo B/Apo A1, LDL C/Apo B, Apo B100, and Apo C3/C2 from baseline to Week 12<br><br>The secondary efficacy endpoints will be analysed using the same statistical method used for the primary analysis; however, Dunnett’s test will not be used to evaluate the superiority of the K 877 groups to the placebo group.
<br>                Secondary outcomes for the subgroup:<br>                1. Severity of illness<br>                2. Pain (VAS)<br>                3. Duration of treatment<br>                4. Re-consultation rate<br>                5. Use of medical services<br>                6. Adverse effects related to antibiotic treatment<br>
Duration of Response;Progression-Free Survival;Time to Next Follicular Lymphoma (FL) Therapy;Overall Survival;Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24;Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12;Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood;Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24);Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14;Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2;Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.);Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7);AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7);t1/2 After the Eighth Infusion (Visit 9, Week 7);CL After the Eighth Infusion (Visit 9, Week 7);Vss After the Eighth Infusion (Visit 9, Week 7)
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Number of Participants With Treatment Emergent Adverse Events (AEs);PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765;Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72;Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment;Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment;Percentage of Participants With Normal Alanine Aminotransferase (ALT);Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment;Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment;Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment;Quantitative HBV-DNA 24 Weeks Following End of Treatment
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1. Psychotropic medication in defined daily dosages<br>2. Number of hospital admissions <br>3. Caregiver burden as measured with the Perceived Stress Scale (PSS)<br>4. Mortality<br>All secondary outcomes are measured at baseline, months 3, 6, and 12, and mortality dates are ascertained retrospectively.
Immune response (every 6 months), clinical safety and tolerability at each visit.
Difference in overall survival of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in objective response rate (ORR) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in duration of response of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin
Secondary end point(s): - Percentage of subjects achieving at least 30% improvement from baseline based on the primary efficacy endpoint;<br>- Physician and Subject Global Assessment of study drug;<br>- Change in the 11-point Likert scale from the baseline mean pain score to the mean pain score during each week of the Treatment Period; <br>- Percentage of subjects achieving pre-specified pain reduction thresholds (e.g., 20% to 100%); and<br>- Opioid consumption, BPI (short-form), average pain the past 24 hours, least pain in past 24 hours, and worst pain in past 24 hours.<br>;Timepoint(s) of evaluation of this end point: Day 36 visit
Ergometric power increase;Subjective health Status - Mental Health Composite Score;Subjective health Status - Physical Health Composite Score;Organ complications
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.;Overall Response Rate;Clinical Benefit Response;Carbohydrate Antigen 19-9 (CA19-9) Response;Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).;Rate of Venous Thromboembolic Events (VTE)
Overall Survival (OS);Proportion of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR);Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab;PK: Plasma Concentration of Merestinib;Number of Participants with Treatment-Emergent Anti-Ramucirumab Antibodies;Change from Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep);Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
to conduct molecular and clinical analyses to assess the presence of predictive markers of benefit [ Tumour tissue blocks at diagnosis and at surgery are mandatory. bloods/serum and plasma at baseline and after the chemotherapy treatment is optional. Further tissue samples at other time points are optional and defined in the protocol];Evaluation of the tolerability of the treatment regimens in the different study arms will be measured by using the Common Terminology Criteria for Adverse Events (CTCAE) verison 4.0[Duration of study up to 28 days after treatment (if surgery not performed) or surgery];Overall Survival in the study arms of abraxane vs paclitaxel[Overall Survival is defined as the time from randomisation to the date of death. Patients alive at the end of the study (10 years) will be considered at their last contact.];to compare Event Free Survival (Distant, Local, Regional) in the study arms of abraxane vs paclitaxel[ diagnosis of breast cancer progression during treatment or recurrence after surgery will be assessed by the investigator and confirmed by clinical, laboratory, radiological and/or histological findings. The protocol defines what is considered acceptable to confirm the event free survivals listed above. After surgery patients will be follwed up for 10 years after surgery. ];clinical Overall Response (cOR) after the first 4 cycles of abraxane vs paclitaxel, and after the entire pre-operative chemotherapy (before surgery) in the study arms of abraxane vs paclitaxel[after 4 cycles and before surgery by palpation of the breast and axilla.]
To evaluate progression-free survival (PFS) in each arm.Timepoint: Nil
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1. Incidence of atopic dermatitis after treatment and until end of 3 years<br>2. Time until the first manifestation of an AD<br>3. Severity of AD at manifestation of an eczema: SCORing Atopic Dermatitis (SCORAD) Score<br>4. Frequency and time until the appearance  as well as severity of allergic/atopic manifestations in the gastrointestinal tract<br>5. Frequency and until the appearance as well as severity of an allergic/atopic manifestation in the airways<br>6. Frequency of a sensitization against food allergens<br>7. Induction / enhancement of a Th1-immune response<br>8. Toll-like-receptors<br>9. Safety pharmacological Investigations before and at the end of the treatment as well as the observation period<br>10. Adverse events
anti-tumour activity of lapatinib in terms of overall response rate;anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival
Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.;Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.;Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
Secondary end point(s): PHASE I:<br>Secondary:<br>•Adverse events during combination therapy<br>•Tumor related results of therapy or death<br>•Treatment administration (dose reductions of chemotherapy, duration of treatment)<br>•Time to recovery after end of treatment<br>•Stem cell mobilization<br><br>PHASE II:<br>Secondary efficacy endpoints:<br>•CT-based tumor status after induction therapy<br>•PET/CT-based tumor status after induction therapy<br>•Progression free survival (PFS)<br>•Overall Survival (OS)<br>;Timepoint(s) of evaluation of this end point: Phase I:<br>During and directly after therapy<br><br>Phase II:<br>Restaging after therapy and follow-up of two years
Secondary end point(s): 1) Change of the SIRS score between visits, and between EOT and final examination<br>2) Number (percentage) of patients with bacteriological success at main examination (EOT)<br>3) Evaluation of therapeutic success at EOT by the investigator and by the patient<br>4) Evaluation of overall therapeutic success by the investigator at the final examination visit<br>5) Number (percentage) of patients with clinical relapse / re-infection at the final examination visit<br>;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index;Change From Baseline in Daily Corticosteroid Dose at Week 24;Change From Baseline in Daily Corticosteroid Dose at Week 48
comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria;establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).
Secondary end point(s): •Left ventricular ejection fraction<br>•Left ventricular end diastolic diameter<br>•Left ventricular global longitudinal systolic strain and systolic strain rate<br>•The 6-minute walk test<br>•New York Heart Association classification<br>•Reduction in the number of angina/chest discomfort episodes<br>•Parvovirus B19 replication; mRNA/DNA loads<br>•Myocardial inflammatory status (CD3+ cells)<br>•Skeletal muscle inflammatory status (CD3+ cells)<br><br>Safety endpoints:<br>Registration of exercise related adverse events and laboratory changes (Blood examination including (sodium, potassium, creatinine, haemoglobin, white and red blood cell counts, thrombocytes count, Nt-proBNP, creatine kinase MM and MB, Cardiac Troponin T, AST, ALT).<br><br>;Timepoint(s) of evaluation of this end point: •LVEF: at baseline (D0±1), week 12<br>•LVEDD: at baseline (D0±1) and week 12<br>•6MWT: at baseline (D0±1) and week 12<br>•NYHA classification: at baseline (D0±1) and at weeks 4,8, 12<br>•Number of angina/chest discomfort episodes: at baseline (D0±1) and weeks 4,8, 12<br>•Biopsy; B19 RNA/cDNA; CD3+ lymphocytes: at week 12<br>• Skeletal muscle biopsy:  at baseline (D0±1) and at week 12<br><br>Safety endpoints (hematological and clinical laboratory analysis): Before the start of treatment (D0-X)±1) and at baseline (D0±1), week 4,8, 12
Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs;Time to First Acute IPF Exacerbation;Incidence of Patients With at Least One Acute IPF Exacerbation Over Time;Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation;Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease;Progression-Free Survival;Overall Survival
No secondary outcome measures