Date/Time of Define-XML document generation: 2025-10-29T15:03:00

Define-XML version: 2.1.10

Define-XML Context: Submission

Stylesheet version: 2019-02-11

Study Name
CDISC-Sample
Study Description
CDISC-Sample Data Definition
Protocol Name
CDISC-Sample
Metadata Name
Study CDISC-Sample, Data Definitions
Metadata Description
Study CDISC-Sample, Data Definitions

Standards for Study CDISC-Sample

Standards for Study CDISC-Sample
StandardTypeStatusDocumentation
ADaMIG 1.1IGFinal
CDISC/NCI ADaM 2017-09-29CTFinal

ADaM specific CT is applicable for a few variables only.

CDISC/NCI SDTM 2018-06-29CTFinal

SDTM CT is applicable for variables copied from SDTM to ADaM.

CDISC/NCI DEFINE-XML 2025-09-26CTFinal

This is the CDISC CT Package 60 (2025-09-26) associated to the CDISC Define-XML Specification Version 2.1.10.


Analysis Results Metadata - Summary

Table 14-3.01Primary Endpoint Analysis: ADAS-Cog - Summary at Week 24 - LOCF (Efficacy Population)

Dose response analysis for ADAS-Cog changes from baseline

Pairwise comparisons to placebo for ADAS-Cog changes from baseline

Table 14-5.02Incidence of Treatment Emergent Serious Adverse Events by Treatment Group

Incidence of Treatment Emergent Serious Adverse Events by Treatment Group


Analysis Results Metadata - Detail

Table 14-3.01
DisplayTable 14-3.01 [2 ] Primary Endpoint Analysis: ADAS-Cog - Summary at Week 24 - LOCF (Efficacy Population)
Analysis ResultDose response analysis for ADAS-Cog changes from baseline
Analysis Parameter(s)PARAMCD = "ACTOT" (Adas-Cog(11) Subscore)
Analysis Variable(s)

ADQSADAS.CHG (Change from Baseline)

Analysis ReasonSPECIFIED IN SAP
Analysis PurposePRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)
ADQSADAS [PARAMCD = "ACTOT" and AVISIT = "Week 24" and EFFFL = "Y" and ANL01FL = "Y"]
DocumentationLinear model analysis of CHG for dose response; using randomized dose (0 for placebo; 54 for low dose; 81 for high dose) and site group in model. Used PROC GLM in SAS to produce p-value (from Type III SS for treatment dose).

SAP Section 10.1.1 [4 ]

Programming Statements[SAS version 9.2]
proc glm data = ADQSADAS;
  where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT";
  class SITEGR1;
  model CHG = TRTPN SITEGR1;
run;
Analysis ResultPairwise comparisons to placebo for ADAS-Cog changes from baseline
Analysis Parameter(s)PARAMCD = "ACTOT" (Adas-Cog(11) Subscore)
Analysis Variable(s)

ADQSADAS.CHG (Change from Baseline)

Analysis ReasonSPECIFIED IN SAP
Analysis PurposePRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)
ADQSADAS [PARAMCD = "ACTOT" and AVISIT = "Week 24" and EFFFL = "Y" and ANL01FL = "Y"]
DocumentationANCOVA analysis of CHG performed to provide pairwise comparisons among treatment groups and adjusted means; using randomized treatment as class variable and site group as class variable in model and the baseline value as a covariate.

SAP Section 10.1.1 [4 ]

Programming Statements[SAS version 9.2]
proc glm data = ADQSADAS;
  where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT";
  class TRTPN SITEGR1;
  model CHG = TRTPN SITEGR1 BASE;
  means TRTPN;
  lsmeans TRTPN / OM STDERR PDIFF CL;
run;

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Table 14-5.02
DisplayTable 14-5.02 [3 ] Incidence of Treatment Emergent Serious Adverse Events by Treatment Group
Analysis ResultIncidence of Treatment Emergent Serious Adverse Events by Treatment Group
Analysis Parameter(s)
Analysis Variable(s)

ADAE.AEBODSYS (Body System or Organ Class)

ADAE.AEDECOD (Dictionary-Derived Term)

Analysis ReasonSPECIFIED IN SAP
Analysis PurposePRIMARY OUTCOME MEASURE
Data References (incl. Selection Criteria)
ADAE [TRTEMFL = "Y" and AESER = "Y"]
ADSL [SAFFL = "Y"]

Get denominators for percentages from ADSL and counts and numerators from ADAE. Join ADAE with ADSL based on the unique subject identifier (USUBJID) keeping only records in ADAE for the numerator.

DocumentationUnique count of subjects that experienced an Adverse Event by Preferred Term, System Organ Class, and Treatment Group and percentages based on the number of subjects in the safety population within each treatment group. The total number of times an event occurred was recorded by Preferred Term, System Organ Class, and Treatment Group. Fisher's exact test was used for treatment comparison of event rates.

SAP Section 11.2 [5 ]

Programming Statements[SAS version 9.2]

at14-5-02.sas

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Datasets

Datasets
DatasetDescriptionClass - SubClassStructurePurposeKeysDocumentationLocation
ADSL[ADaMIG 1.1]Subject-Level AnalysisSUBJECT LEVEL ANALYSIS DATASETone record per subjectAnalysisSTUDYID, USUBJID

Screen Failures are excluded since they are not needed for this study analysis. See referenced dataset creation program and ADRG

adsl.sas

Analysis Data Reviewer's Guide [6 ]

adsl.xpt
ADQSADAS[ADaMIG 1.1]ADAS-Cog AnalysisBASIC DATA STRUCTUREOne record per subject per parameter per analysis visit per analysis dateAnalysisSTUDYID, USUBJID, PARAMCD, AVISIT, ADT

See referenced dataset creation program and ADRG

adqsadas.sas

Analysis Data Reviewer's Guide [Section2.1 ]

adqsadas.xpt
ADAE[ADaMIG 1.1]Adverse Events Analysis DatasetOCCURRENCE DATA STRUCTURE
  • ADVERSE EVENT
one record per subject per adverse eventAnalysisSTUDYID, USUBJID, AETERM, ASTDT, AESEQ

See SAS program

adae.sas

adae.xpt

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Subject-Level Analysis (ADSL)

ADSL (Subject-Level Analysis) - [ADaMIG 1.1]Location: adsl.xpt
VariableLabel / DescriptionTypeLength or Display FormatControlled Terms or ISO FormatOrigin / Source / Method / Comment
STUDYIDStudy Identifiertext12
Predecessor: DM.STUDYID
USUBJIDUnique Subject Identifiertext11
Predecessor: DM.USUBJID
SUBJIDSubject Identifier for the Studytext4
Predecessor: DM.SUBJID
SITEIDStudy Site Identifiertext3
Predecessor: DM.SITEID
SITEGR1Pooled Site Group 1text3
Derived (Source: Sponsor)
refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900
ARMDescription of Planned Armtext20Actual Treatment
  • • "Placebo"
  • • "Xanomeline Low Dose"
  • • "Xanomeline High Dose"
Predecessor: DM.ARM
TRT01PPlanned Treatment for Period 01text20Actual Treatment
  • • "Placebo"
  • • "Xanomeline Low Dose"
  • • "Xanomeline High Dose"
Predecessor: DM.ARM
TRT01PNPlanned Treatment for Period 01 (N)integer2Actual Treatment (N)
  • • 0 = "Placebo"
  • • 54 = "Xanomeline Low Dose"
  • • 81 = "Xanomeline High Dose"
Assigned (Source: Sponsor)

Numeric code for TRT01P

TRT01AActual Treatment for Period 01text20Actual Treatment
  • • "Placebo"
  • • "Xanomeline Low Dose"
  • • "Xanomeline High Dose"
Assigned (Source: Sponsor)

TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.

TRT01ANActual Treatment for Period 01 (N)integer2Actual Treatment (N)
  • • 0 = "Placebo"
  • • 54 = "Xanomeline Low Dose"
  • • 81 = "Xanomeline High Dose"
Assigned (Source: Sponsor)

Numeric code for TRT01A

TRTSDTDate of First Exposure to Treatmentintegerdate9.
Derived (Source: Sponsor)
SV.SVSTDTC where SV.VISITNUM=3, converted to SAS date
TRTEDTDate of Last Exposure to Treatmentintegerdate9.
Derived (Source: Sponsor)
The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.
TRTDURDTotal Treatment Duration (Days)integer3
Derived (Source: Sponsor)
TRTEDT-TRTSDT+1
AVGDDAvg Daily Dose (as planned)float5.1
Derived (Source: Sponsor)
CUMDOSE/TRTDURD
CUMDOSECumulative Dose (as planned)float8.1
Derived (Source: Sponsor)
For TRT01PN=0 or 54: CUMDOSE=TRT01PN*TRTDURD. For TRT01PN=81: CUMDOSE will be based on 54 mg per day for the # of days subject was in 1st dosing interval (i.e., Date of visit 4 - TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subject discontinued <= Visit 4 (Week 4) and > Visit 3 (Baseline)), 81 mg per day for the # of days subject was in 2nd dosing interval (i.e., Date of Visit 12 - Date of Visit 4 if 2nd interval completed, TRTEDT- Date of Visit 4 if subject discontinued <= Visit 12 (Week 24) and > Visit 4), and 54 mg per day for the # of days subject was in 3rd dosing interval (i.e., TRTEDT - Date of Visit 12 if subject continued after Visit 12).
AGEAgeinteger2
Predecessor: DM.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • • "<65"
  • • "65-80"
  • • ">80"
Derived (Source: Sponsor)
Grouping of AGE into <65, 65-80, and >80
AGEGR1NPooled Age Group 1 (N)integer2Age Group (N)
  • • 1 = "<65"
  • • 2 = "65-80"
  • • 3 = ">80"
Assigned (Source: Sponsor)

Numeric code for AGEGR1

AGEUAge Unitstext5Age Unit
  • • "YEARS"
Predecessor: DM.AGEU
RACERacetext32Race
  • • "WHITE"
  • • "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN"
  • • "AMERICAN INDIAN OR ALASKA NATIVE"
Predecessor: DM.RACE
RACENRace (N)integer1Race (N)
  • • 1 = "WHITE"
  • • 2 = "BLACK OR AFRICAN AMERICAN"
  • • 6 = "AMERICAN INDIAN OR ALASKA NATIVE"
  • • 7 = "ASIAN"
Assigned (Source: Sponsor)

Numeric code for RACE

SEXSextext1Sex
  • • "F" = "Female"
  • • "M" = "Male"
  • • "U" = "Unknown"
Predecessor: DM.SEX
ETHNICEthnicitytext22Ethnic Group
  • • "HISPANIC OR LATINO"
  • • "NOT HISPANIC OR LATINO"
Predecessor: DM.ETHNIC
SAFFLSafety Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if ITTFL='Y' and TRTSDT ne missing. N otherwise
ITTFLIntent-To-Treat Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if ARMCD ne ' '. N otherwise
EFFFLEfficacy Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with QS.VISITNUM>3 AND at least one record in QS for CIBIC+ with QS.VISITNUM>3, N otherwise
COMP8FLCompleters of Week 8 Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise
COMP16FLCompleters of Week 16 Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if subject has a SV.VISITNUM=10 and TRTEDT>=date of visit 10, N otherwise
COMP24FLCompleters of Week 24 Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if subject has a SV.VISITNUM=12 and TRTEDT>= date of visit 12 , N otherwise
DISCONFLSubject Discontinued Study Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if EOSSTT='DISCONTINUED'. Null otherwise
DSRAEFLSubject Discontinued due to AE Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Y if DCSREAS='Adverse Event'. Null otherwise
DTHFLSubject Death Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Predecessor: DM.DTHFL
BMIBLBaseline BMI (kg/m^2)float5.1
Derived (Source: Sponsor)
WEIGHTBL / ((HEIGHTBL*100)**2)
BMIBLGR1Pooled Baseline BMI Group 1text6Body Mass Index Category
  • • "<25" = "Normal"
  • • "25-<30" = "Overweight"
  • • ">30" = "Obese"
Derived (Source: Sponsor)
BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30
HEIGHTBLBaseline Height (cm)float6.1
Derived (Source: Sponsor)
VS.VSSTRESN where VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1
WEIGHTBLBaseline Weight (kg)float6.1
Derived (Source: Sponsor)
VS.VSSTRESN where VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3
EDUCLVLYears of Educationinteger2
Derived (Source: Sponsor)
SC.SCSTRESN where SC.SCTESTCD="EDLEVEL"
DISONDTDate of Onset of Diseaseintegerdate9.
Derived (Source: Sponsor)
MH.MHSTDTC where MH.MHCAT='PRIMARY DIAGNOSIS' converted to SAS date
DURDISDuration of Disease (Months)float6.1
Derived (Source: Sponsor)
number of months between Date of VISIT 1 and DISONDT
DURDSGR1Pooled Disease Duration Group 1text4Disease Duration Group
  • • "<12"
  • • ">=12"
Derived (Source: Sponsor)
grouping DURDIS values as <12 and >=12
VISIT1DTDate of Visit 1integerdate9.
Derived (Source: Sponsor)
SV.SVSTDTC where SV.VISITNUM=1, converted to SAS date
RFSTDTCSubject Reference Start Date/TimedateISO 8601
Predecessor: DM.RFSTDTC
RFENDTCSubject Reference End Date/TimedateISO 8601
Predecessor: DM.RFENDTC
VISNUMENEnd of Trt Visit (Vis 12 or Early Term.)integer2
Derived (Source: Sponsor)
If DS.VISITNUM=13 where DS.DSTERM='PROTOCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DS.DSTERM='PROTOCOL COMPLETED'
RFENDTDate of Discontinuation/Completioninteger5
Derived (Source: Sponsor)
RFENDTC converted to SAS date
EOSSTTEnd of Study Statustext12Subject Trial Status
  • • "COMPLETED"
  • • "DISCONTINUED"
Derived (Source: Sponsor)
If DS.DSDECOD='COMPLETED' then EOSSTT='COMPLETED'. Otherwise EOSSTT='DISCONTINUED'.
DCSREASReason for Discontinuation from Studytext18Reason for Discontinuation

[10 Terms]

Derived (Source: Sponsor)
If DS.DSCAT='DISPOSITION EVENT' and DS.DSTERM in('I/E NOT MET' 'SPONSOR DECISION' 'WITHDREW CONSENT') then DCSREAS=DS.DSTERM. Otherwise if DS.DSCAT='DISPOSITION EVENT' then DCSREAS=DS.DSDECOD. Convert to mixed case to match display format.
EOSDISPStandardized Disposition Termtext27Completion/Reason for Non-Completion

[9 Terms]

Predecessor: DS.DSDECOD where DS.DSCAT='DISPOSITION EVENT'
MMS1TSBLMMS1-Total Score at Baselineinteger2
Derived (Source: Sponsor)
Sum of FT.FTSTRESN values where FT.FTCAT="MMSE" for the subject (FT.FTTESTCD= 'MMS101A'-'MMS111')

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ADAS-Cog Analysis (ADQSADAS)

ADQSADAS (ADAS-Cog Analysis) - [ADaMIG 1.1]Location: adqsadas.xpt
VariableWhere ConditionLabel / DescriptionTypeLength or Display FormatControlled Terms or ISO FormatOrigin / Source / Method / Comment
STUDYIDStudy Identifiertext12
Predecessor: ADSL.STUDYID
SITEIDStudy Site Identifiertext3
Predecessor: ADSL.SITEID
SITEGR1Pooled Site Group 1text3
Predecessor: ADSL.SITEGR1
USUBJIDUnique Subject Identifiertext11
Predecessor: ADSL.USUBJID
TRTSDTDate of First Exposure to Treatmentintegerdate9.
Predecessor: ADSL.TRTSDT
TRTEDTDate of Last Exposure to Treatmentintegerdate9.
Predecessor: ADSL.TRTEDT
TRTPPlanned Treatmenttext20Actual Treatment
  • • "Placebo"
  • • "Xanomeline Low Dose"
  • • "Xanomeline High Dose"
Predecessor: ADSL.TRT01P
TRTPNPlanned Treatment (N)integer2Actual Treatment (N)
  • • 0 = "Placebo"
  • • 54 = "Xanomeline Low Dose"
  • • 81 = "Xanomeline High Dose"
Predecessor: ADSL.TRT01PN
AGEAgeinteger2
Predecessor: ADSL.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • • "<65"
  • • "65-80"
  • • ">80"
Predecessor: ADSL.AGEGR1
AGEGR1NPooled Age Group 1 (N)integer1Age Group (N)
  • • 1 = "<65"
  • • 2 = "65-80"
  • • 3 = ">80"
Predecessor: ADSL.AGEGR1N
RACERacetext32Race
  • • "WHITE"
  • • "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN"
  • • "AMERICAN INDIAN OR ALASKA NATIVE"
Predecessor: ADSL.RACE
RACENRace (N)integer1Race (N)
  • • 1 = "WHITE"
  • • 2 = "BLACK OR AFRICAN AMERICAN"
  • • 6 = "AMERICAN INDIAN OR ALASKA NATIVE"
  • • 7 = "ASIAN"
Predecessor: ADSL.RACEN
SEXSextext1Sex
  • • "F" = "Female"
  • • "M" = "Male"
  • • "U" = "Unknown"
Predecessor: ADSL.SEX
ITTFLIntent-To-Treat Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: ADSL.ITTFL
EFFFLEfficacy Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: ADSL.FASFL
COMP24FLCompleters of Week 24 Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: ADSL.COMP24FL
AVISITAnalysis Visittext16Analysis Visit
  • • "Baseline"
  • • "Week 8"
  • • "Week 16"
  • • "Week 24"
Derived (Source: Sponsor)
Derived based on windowing algorithm described in SAP, Section 8.2
AVISITNAnalysis Visit (N)integer5Analysis Visit (N)
  • • 0 = "Baseline"
  • • 8 = "Week 8"
  • • 16 = "Week 16"
  • • 24 = "Week 24"
Assigned (Source: Sponsor)

Numeric code for AVISIT

VISITVisit Nametext19Visit

[37 Terms]

Predecessor: QS.VISIT
VISITNUMVisit Numberfloat5.1Visit Number

[37 Terms]

Predecessor: QS.VISITNUM
ADYAnalysis Relative Dayinteger3
Derived (Source: Sponsor)
ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT.
ADTAnalysis Dateintegerdate9.
Derived (Source: Sponsor)
SAS date from QS.QSDTC
PARAMParametertext100ADAS-Cog Parameter

[15 Terms]

Assigned (Source: Sponsor)
PARAMCDParameter Codetext8ADAS-Cog Parameter Code

[15 Terms]

Assigned (Source: Sponsor)
PARAMNParameter (N)integer2ADAS-Cog Parameter Code (N)

[15 Terms]

Assigned (Source: Sponsor)

Numeric code for PARAM

AVALVLMAnalysis Valueinteger3
PARAMCD IN (
"ACITM01" (Word Recall Task),
"ACITM02" (Naming Objects And Fingers (Refer To 5 C),
"ACITM03" (Delayed Word Recall),
"ACITM04" (Commands),
"ACITM05" (Constructional Praxis),
"ACITM06" (Ideational Praxis),
"ACITM07" (Orientation),
"ACITM08" (Word Recognition),
"ACITM09" (Attention/Visual Search Task),
"ACITM10" (Maze Solution),
"ACITM11" (Spoken Language Ability),
"ACITM12" (Comprehension Of Spoken Language),
"ACITM13" (Word Finding Difficulty In Spontaneous Speech),
"ACITM14" (Recall Of Test Instructions)
) 		Analysis Valueinteger2
Predecessor: QS.QSSTRESN where QS.QSTESTCD=ADQSADAS.PARAMCD
PARAMCD = "ACTOT" (Adas-Cog(11) Subscore)Analysis Valueinteger3
Derived (Source: Sponsor)
Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see ADRG for details on adjusting for missing values.

Analysis Data Reviewer's Guide [3 ]

BASEBaseline Valueinteger2
Derived (Source: Sponsor)
QS.QSSTRESN where QS.QSBLFL=Y (QS.VISITNUM=3)
CHGChange from Baselineinteger8
Derived (Source: Sponsor)
AVAL - BASE
PCHGPercent Change from Baselineinteger8
Derived (Source: Sponsor)
100* (CHG/BASE)
ABLFLBaseline Record Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Predecessor: QS.QSBLFL
ANL01FLAnalysis Flag 01text1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
If multiple visits fall into the same visit window, then the one closest to the target day is chosen for analysis. These are flagged with ANL01FL="Y".
DTYPEVLMDerivation Typetext7Derivation Type
  • • "LOCF" = "Last Observation Carried Forward"
PARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore)Derivation Typetext7Derivation Type
  • • "LOCF" = "Last Observation Carried Forward"
Assigned (Source: Sponsor)

Value: null

PARAMCD = "ACTOT" (Adas-Cog(11) Subscore)Derivation Typetext7Derivation Type
  • • "LOCF" = "Last Observation Carried Forward"
Assigned (Source: Sponsor)

Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit.

AWRANGEAnalysis Window Valid Relative Rangetext9Analysis Window Range
  • • "<=1"
  • • "2-84"
  • • "85-140"
  • • ">140"
Assigned (Source: Sponsor)

Window range, specified in the SAP.

AWTARGETAnalysis Window Targetinteger8
Assigned (Source: Sponsor)

Target day within the window, specified in the SAP.

AWTDIFFAnalysis Window Diff from Targetinteger8
Derived (Source: Sponsor)
Absolute difference between AWTARGET and ADY
AWLOAnalysis Window Beginning Timepointinteger8
Assigned (Source: Sponsor)

Start day of the window, specified in the SAP.

AWHIAnalysis Window Ending Timepointinteger8
Assigned (Source: Sponsor)

End day of the window, specified in the SAP.

AWUAnalysis Window Unittext4Unit - AWU
  • • "DAYS"
Assigned (Source: Sponsor)

Assigned as "DAYS".

QSSEQVLMSequence Numberinteger4
PARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore)Sequence Numberinteger4
Predecessor: QS.QSSEQ
PARAMCD = "ACTOT" (Adas-Cog(11) Subscore)Sequence Numberinteger3
Assigned (Source: Sponsor)

Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT.

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Adverse Events Analysis Dataset (ADAE)

ADAE (Adverse Events Analysis Dataset) - [ADaMIG 1.1]Location: adae.xpt
VariableLabel / DescriptionTypeLength or Display FormatControlled Terms or ISO FormatOrigin / Source / Method / Comment
STUDYIDStudy Identifiertext12
Predecessor: ADSL.STUDYID
SITEIDStudy Site Identifiertext3
Predecessor: ADSL.SITEID
USUBJIDUnique Subject Identifiertext11
Predecessor: ADSL.USUBJID
TRTAActual Treatmenttext20Actual Treatment
  • • "Placebo"
  • • "Xanomeline Low Dose"
  • • "Xanomeline High Dose"
Predecessor: ADSL.TRT01A
TRTANActual Treatment (N)integer2Actual Treatment (N)
  • • 0 = "Placebo"
  • • 54 = "Xanomeline Low Dose"
  • • 81 = "Xanomeline High Dose"
Predecessor: ADSL.TRT01AN
AGEAgeinteger2
Predecessor: ADSL.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • • "<65"
  • • "65-80"
  • • ">80"
Predecessor: ADSL.AGEGR1
AGEGR1NPooled Age Group 1 (N)integer1Age Group (N)
  • • 1 = "<65"
  • • 2 = "65-80"
  • • 3 = ">80"
Predecessor: ADSL.AGEGR1N
RACERacetext32Race
  • • "WHITE"
  • • "BLACK OR AFRICAN AMERICAN"
  • • "ASIAN"
  • • "AMERICAN INDIAN OR ALASKA NATIVE"
Predecessor: ADSL.RACE
RACENRace (N)integer1Race (N)
  • • 1 = "WHITE"
  • • 2 = "BLACK OR AFRICAN AMERICAN"
  • • 6 = "AMERICAN INDIAN OR ALASKA NATIVE"
  • • 7 = "ASIAN"
Predecessor: ADSL.RACEN
SEXSextext1Sex
  • • "F" = "Female"
  • • "M" = "Male"
  • • "U" = "Unknown"
Predecessor: ADSL.SEX
SAFFLSafety Population Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: ADSL.SAFFL
TRTSDTDate of First Exposure to Treatmentintegerdate9.
Predecessor: ADSL.TRTSDT
TRTEDTDate of Last Exposure to Treatmentintegerdate9.
Predecessor: ADSL.TRTEDT
ASTDTAnalysis Start Dateintegerdate9.
Derived (Source: Sponsor)
AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.
ASTDTFAnalysis Start Date Imputation Flagtext1Date Imputation Flag
  • • "D" = "Day Imputed: Day is imputed"
  • • "M" = "Month Imputed: Month and day are imputed"
  • • "Y" = "Year Imputed: Entire date (year, month and day) is imputed"
Derived (Source: Sponsor)
ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study
ASTDYAnalysis Start Relative Dayinteger5
Derived (Source: Sponsor)
IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT
AENDTAnalysis End Dateintegerdate9.
Derived (Source: Sponsor)
AE.AEENDTC, converted to a numeric SAS date
AENDYAnalysis End Relative Dayinteger4
Derived (Source: Sponsor)
IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT
ADURNAnalysis Duration (N)integer3
Derived (Source: Sponsor)
ADURN=AENDT-ASTDT+1
ADURUAnalysis Duration Unitstext3
Derived (Source: Sponsor)
If ADURN is not missing then ADURU='DAY'
AETERMReported Term for the Adverse Eventtext46
Predecessor: AE.AETERM
AELLTLowest Level Termtext46Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AELLT
AELLTCDLowest Level Term Codeinteger8Adverse Event Dictionary (N)

MedDRA 8.0

Predecessor: AE.AELLTCD
AEDECODDictionary-Derived Termtext46Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEDECOD
AEPTCDPreferred Term Codeinteger8Adverse Event Dictionary (N)

MedDRA 8.0

Predecessor: AE.AEPTCD
AEHLTHigh Level Termtext8Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEHLT
AEHLTCDHigh Level Term Codeinteger8Adverse Event Dictionary (N)

MedDRA 8.0

Predecessor: AE.AEHLTCD
AEHLGTHigh Level Group Termtext9Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEHLGT
AEHLGTCDHigh Level Group Term Codeinteger8Adverse Event Dictionary (N)

MedDRA 8.0

Predecessor: AE.AEHLGTCD
AEBODSYSBody System or Organ Classtext67Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEBODSYS
AESOCPrimary System Organ Classtext67Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AESOC
AESOCCDPrimary System Organ Class Codeinteger8Adverse Event Dictionary (N)

MedDRA 8.0

Predecessor: AE.AESOCCD
AESEVSeverity/Intensitytext8Severity/Intensity Scale for Adverse Events
  • • "MILD" = "Grade 1"
  • • "MODERATE" = "Grade 2"
  • • "SEVERE" = "Grade 3"
Predecessor: AE.AESEV
AESERSerious Eventtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESER
AESCANInvolves Cancertext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESCAN
AESCONGCongenital Anomaly or Birth Defecttext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESCONG
AESDISABPersist or Signif Disability/Incapacitytext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESDISAB
AESDTHResults in Deathtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESDTH
AESHOSPRequires or Prolongs Hospitalizationtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESHOSP
AESLIFEIs Life Threateningtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESLIFE
AESODOccurred with Overdosetext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Predecessor: AE.AESOD
AERELCausalitytext8Causality
  • • "NONE"
  • • "POSSIBLE"
  • • "PROBABLE"
  • • "REMOTE"
Predecessor: AE.AEREL
AEACNAction Taken with Study Treatmenttext1
Predecessor: AE.AEACN
AEOUTOutcome of Adverse Eventtext26Outcome of Adverse Event
  • • "RECOVERED/RESOLVED"
  • • "NOT RECOVERED/NOT RESOLVED"
  • • "FATAL"
Predecessor: AE.AEOUT
AESEQSequence Numberinteger8
Predecessor: AE.AESEQ
TRTEMFLTreatment Emergent Analysis Flagtext1No Yes Response
  • • "N" = "No"
  • • "Y" = "Yes"
Derived (Source: Sponsor)
If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'
AOCCFL1st Occurrence within Subject Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=’Y’) within each Subject
AOCCSFL1st Occurrence of SOC Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=’Y’) within each Subject and SOC
AOCCPFL1st Occurrence of Preferred Term Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=’Y’) within each Subject, SOC, and PT
AOCC02FL1st Occurrence of Serious 02 Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=’Y’) within each Subject
AOCC03FL1st Occurrence of Serious SOC 03 Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=’Y’) within each Subject and SOC
AOCC04FL1st Occurrence of Serious PT 04 Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=’Y’) within each Subject, SOC, and PT
CQ01NAMCustomized Query 01 Nametext19
Derived (Source: Sponsor)
If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL
AOCC01FL1st Occurrence of CQ01 01 Flagtext1No Yes Response - Y subset
  • • "Y" = "Yes"
Derived (Source: Sponsor)
Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=’Y’) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)

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CodeLists

Age Group[Non Standard]
Permitted Value (Code)Rank
<651
65-802
>803
Age Group (N)[Non Standard]
Permitted Value (Code)Display Value (Decode)
1<65
265-80
3>80
Age Unit [C66781][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
YEARS [C29848]
Actual Treatment[Non Standard]
Permitted Value (Code)
Placebo
Xanomeline Low Dose
Xanomeline High Dose
Actual Treatment (N)[Non Standard]
Permitted Value (Code)Display Value (Decode)
0Placebo
54Xanomeline Low Dose
81Xanomeline High Dose
Analysis Visit[Non Standard]
Permitted Value (Code)
Baseline
Week 8
Week 16
Week 24
Analysis Visit (N)[Non Standard]
Permitted Value (Code)Display Value (Decode)
0Baseline
8Week 8
16Week 16
24Week 24
Unit - AWU [C71620][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
DAYS [C25301]
Body Mass Index Category[Non Standard]
Permitted Value (Code)Display Value (Decode)Rank
<25Normal1
25-<30Overweight2
>30Obese3
Date Imputation Flag [C81223][CDISC/NCI ADaM 2017-09-29]
Permitted Value (Code)Display Value (Decode)
D [C81212]Day Imputed: Day is imputed
M [C81211]Month Imputed: Month and day are imputed
Y [C81210]Year Imputed: Entire date (year, month and day) is imputed
Completion/Reason for Non-Completion [C66727][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
COMPLETED [C25250]
ADVERSE EVENT [C41331]
DEATH [C28554]
LACK OF EFFICACY [C48226]
LOST TO FOLLOW-UP [C48227]
PHYSICIAN DECISION [C48250]
PROTOCOL VIOLATION [C142185]
STUDY TERMINATED BY SPONSOR [C49632]
WITHDRAWAL BY SUBJECT [C49634]
Reason for Discontinuation[Non Standard]
Permitted Value (Code)
Completed
Adverse Event
Death
I/E Not Met
Lack of Efficacy
Lost to Follow-up
Physician Decision
Protocol Violation
Sponsor Decision
Withdrew Consent
Derivation Type [C81224][CDISC/NCI ADaM 2017-09-29]
Permitted Value (Code)Display Value (Decode)
LOCF [C81198]Last Observation Carried Forward
Disease Duration Group[Non Standard]
Permitted Value (Code)Rank
<121
>=122
Subject Trial Status [C124296][CDISC/NCI ADaM 2017-09-29]
Permitted Value (Code)
COMPLETED [C25250]
DISCONTINUED [C25484]
Ethnic Group [C66790][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
HISPANIC OR LATINO [C17459]
NOT HISPANIC OR LATINO [C41222]
ADAS-Cog Parameter Code[Non Standard]
Permitted Value (Code)Display Value (Decode)
ACITM01Word Recall Task
ACITM02Naming Objects And Fingers (Refer To 5 C
ACITM03Delayed Word Recall
ACITM04Commands
ACITM05Constructional Praxis
ACITM06Ideational Praxis
ACITM07Orientation
ACITM08Word Recognition
ACITM09Attention/Visual Search Task
ACITM10Maze Solution
ACITM11Spoken Language Ability
ACITM12Comprehension Of Spoken Language
ACITM13Word Finding Difficulty In Spontaneous Speech
ACITM14Recall Of Test Instructions
ACTOTAdas-Cog(11) Subscore
ADAS-Cog Parameter Code (N)[Non Standard]
Permitted Value (Code)Display Value (Decode)
1Word Recall Task
2Naming Objects And Fingers (Refer To 5 C
3Delayed Word Recall
4Commands
5Constructional Praxis
6Ideational Praxis
7Orientation
8Word Recognition
9Attention/Visual Search Task
10Maze Solution
11Spoken Language Ability
12Comprehension Of Spoken Language
13Word Finding Difficulty In Spontaneous S
14Recall Of Test Instructions
15Adas-Cog(11) Subscore
ADAS-Cog Parameter[Non Standard]
Permitted Value (Code)
Word Recall Task
Naming Objects And Fingers (Refer To 5 C
Delayed Word Recall
Commands
Constructional Praxis
Ideational Praxis
Orientation
Word Recognition
Attention/Visual Search Task
Maze Solution
Spoken Language Ability
Comprehension Of Spoken Language
Word Finding Difficulty In Spontaneous S
Recall Of Test Instructions
Adas-Cog(11) Subscore
Analysis Window Range[Non Standard]
Permitted Value (Code)
<=1
2-84
85-140
>140
Race [C74457][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
WHITE [C41261]
BLACK OR AFRICAN AMERICAN [C16352]
ASIAN [C41260]
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
Race (N)[Non Standard]
Permitted Value (Code)Display Value (Decode)
1WHITE
2BLACK OR AFRICAN AMERICAN
6AMERICAN INDIAN OR ALASKA NATIVE
7ASIAN
Sex [C66731][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)Display Value (Decode)
F [C16576]Female
M [C20197]Male
U [C17998]Unknown
Visit[Non Standard]
Permitted Value (Code)
SCREENING 1
UNSCHEDULED 1.1
UNSCHEDULED 1.2
UNSCHEDULED 1.3
SCREENING 2
BASELINE
UNSCHEDULED 3.1
AMBUL ECG PLACEMENT
WEEK 2
UNSCHEDULED 4.1
UNSCHEDULED 4.2
WEEK 4
UNSCHEDULED 5.1
AMBUL ECG REMOVAL
UNSCHEDULED 6.1
WEEK 6
UNSCHEDULED 7.1
WEEK 8
WEEK 10 (T)
UNSCHEDULED 8.2
WEEK 12
WEEK 14 (T)
UNSCHEDULED 9.2
UNSCHEDULED 9.3
WEEK 16
WEEK 18 (T)
UNSCHEDULED 10.2
WEEK 20
WEEK 22 (T)
UNSCHEDULED 11.2
WEEK 24
UNSCHEDULED 12.1
WEEK 26
UNSCHEDULED 13.1
AE FOLLOW-UP
RETRIEVAL
Rash followup
Visit Number[Non Standard]
Permitted Value (Code)Display Value (Decode)
1SCREENING 1
1.1UNSCHEDULED 1.1
1.2UNSCHEDULED 1.2
1.3UNSCHEDULED 1.3
2SCREENING 2
3BASELINE
3.1UNSCHEDULED 3.1
3.5AMBUL ECG PLACEMENT
4WEEK 2
4.1UNSCHEDULED 4.1
4.2UNSCHEDULED 4.2
5WEEK 4
5.1UNSCHEDULED 5.1
6AMBUL ECG REMOVAL
6.1UNSCHEDULED 6.1
7WEEK 6
7.1UNSCHEDULED 7.1
8WEEK 8
8.1WEEK 10 (T)
8.2UNSCHEDULED 8.2
9WEEK 12
9.1WEEK 14 (T)
9.2UNSCHEDULED 9.2
9.3UNSCHEDULED 9.3
10WEEK 16
10.1WEEK 18 (T)
10.2UNSCHEDULED 10.2
11WEEK 20
11.1WEEK 22 (T)
11.2UNSCHEDULED 11.2
12WEEK 24
12.1UNSCHEDULED 12.1
13WEEK 26
13.1UNSCHEDULED 13.1
101AE FOLLOW-UP
201RETRIEVAL
501Rash followup
No Yes Response [C66742][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)Display Value (Decode)
N [C49487]No
Y [C49488]Yes
No Yes Response - Y subset [C66742][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)Display Value (Decode)
Y [C49488]Yes
Severity/Intensity Scale for Adverse Events [C66769][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)Display Value (Decode)Rank
MILD [C41338]Grade 11
MODERATE [C41339]Grade 22
SEVERE [C41340]Grade 33
Causality[Non Standard]
Permitted Value (Code)Rank
NONE1
POSSIBLE2
PROBABLE3
REMOTE4
Outcome of Adverse Event [C66768][CDISC/NCI SDTM 2018-06-29]
Permitted Value (Code)
RECOVERED/RESOLVED [C49498]
NOT RECOVERED/NOT RESOLVED [C49494]
FATAL [C48275]

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External Dictionaries

External Dictionaries
Reference NameExternal DictionaryDictionary Version
Adverse Event DictionaryMedDRA 8.0
Adverse Event Dictionary (N)MedDRA 8.0

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Methods

Methods
MethodTypeDescription
MT.ADQSADAS.AVISITComputation
Derived based on windowing algorithm described in SAP, Section 8.2
MT.ADQSADAS.ADYComputation
ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT.
MT.ADQSADAS.ADTComputation
SAS date from QS.QSDTC
MT.ADQSADAS.BASEComputation
QS.QSSTRESN where QS.QSBLFL=Y (QS.VISITNUM=3)
MT.ADQSADAS.CHGComputation
AVAL - BASE
MT.ADQSADAS.PCHGComputation
100* (CHG/BASE)
MT.ADQSADAS.ANL01FLComputation
If multiple visits fall into the same visit window, then the one closest to the target day is chosen for analysis. These are flagged with ANL01FL="Y".
MT.ADQSADAS.AWTDIFFComputation
Absolute difference between AWTARGET and ADY
MT.ADSL.SITEGR1Computation
refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900
MT.ADSL.TRTSDTComputation
SV.SVSTDTC where SV.VISITNUM=3, converted to SAS date
MT.ADSL.TRTEDTComputation
The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.
MT.ADSL.TRTDURDComputation
TRTEDT-TRTSDT+1
MT.ADSL.AVGDDComputation
CUMDOSE/TRTDURD
MT.ADSL.CUMDOSEComputation
For TRT01PN=0 or 54: CUMDOSE=TRT01PN*TRTDURD. For TRT01PN=81: CUMDOSE will be based on 54 mg per day for the # of days subject was in 1st dosing interval (i.e., Date of visit 4 - TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subject discontinued <= Visit 4 (Week 4) and > Visit 3 (Baseline)), 81 mg per day for the # of days subject was in 2nd dosing interval (i.e., Date of Visit 12 - Date of Visit 4 if 2nd interval completed, TRTEDT- Date of Visit 4 if subject discontinued <= Visit 12 (Week 24) and > Visit 4), and 54 mg per day for the # of days subject was in 3rd dosing interval (i.e., TRTEDT - Date of Visit 12 if subject continued after Visit 12).
MT.ADSL.AGEGR1Computation
Grouping of AGE into <65, 65-80, and >80
MT.ADSL.SAFFLComputation
Y if ITTFL='Y' and TRTSDT ne missing. N otherwise
MT.ADSL.ITTFLComputation
Y if ARMCD ne ' '. N otherwise
MT.ADSL.EFFFLComputation
Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with QS.VISITNUM>3 AND at least one record in QS for CIBIC+ with QS.VISITNUM>3, N otherwise
MT.ADSL.COMP8FLComputation
Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise
MT.ADSL.COMP16FLComputation
Y if subject has a SV.VISITNUM=10 and TRTEDT>=date of visit 10, N otherwise
MT.ADSL.COMP24FLComputation
Y if subject has a SV.VISITNUM=12 and TRTEDT>= date of visit 12 , N otherwise
MT.ADSL.DISCONFLComputation
Y if EOSSTT='DISCONTINUED'. Null otherwise
MT.ADSL.DSRAEFLComputation
Y if DCSREAS='Adverse Event'. Null otherwise
MT.ADSL.BMIBLComputation
WEIGHTBL / ((HEIGHTBL*100)**2)
MT.ADSL.BMIBLGR1Computation
BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30
MT.ADSL.HEIGHTBLComputation
VS.VSSTRESN where VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1
MT.ADSL.WEIGHTBLComputation
VS.VSSTRESN where VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3
MT.ADSL.EDUCLVLComputation
SC.SCSTRESN where SC.SCTESTCD="EDLEVEL"
MT.ADSL.DISONDTComputation
MH.MHSTDTC where MH.MHCAT='PRIMARY DIAGNOSIS' converted to SAS date
MT.ADSL.DURDISComputation
number of months between Date of VISIT 1 and DISONDT
MT.ADSL.DURDSGR1Computation
grouping DURDIS values as <12 and >=12
MT.ADSL.VISIT1DTComputation
SV.SVSTDTC where SV.VISITNUM=1, converted to SAS date
MT.ADSL.VISNUMENComputation
If DS.VISITNUM=13 where DS.DSTERM='PROTOCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DS.DSTERM='PROTOCOL COMPLETED'
MT.ADSL.RFENDTComputation
RFENDTC converted to SAS date
MT.ADSL.EOSSTTComputation
If DS.DSDECOD='COMPLETED' then EOSSTT='COMPLETED'. Otherwise EOSSTT='DISCONTINUED'.
MT.ADSL.DCSREASComputation
If DS.DSCAT='DISPOSITION EVENT' and DS.DSTERM in('I/E NOT MET' 'SPONSOR DECISION' 'WITHDREW CONSENT') then DCSREAS=DS.DSTERM. Otherwise if DS.DSCAT='DISPOSITION EVENT' then DCSREAS=DS.DSDECOD. Convert to mixed case to match display format.
MT.ADSL.MMS1TSBLComputation
Sum of FT.FTSTRESN values where FT.FTCAT="MMSE" for the subject (FT.FTTESTCD= 'MMS101A'-'MMS111')
MT.ADQSADAS.AVAL.ACTOTComputation
Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see ADRG for details on adjusting for missing values.

Analysis Data Reviewer's Guide [3 ]

MT.ADAE.ASTDTComputation
AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.
MT.ADAE.ASTDTFComputation
ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study
MT.ADAE.ASTDYComputation
IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT
MT.ADAE.AENDTComputation
AE.AEENDTC, converted to a numeric SAS date
MT.ADAE.AENDYComputation
IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT
MT.ADAE.ADURNComputation
ADURN=AENDT-ASTDT+1
MT.ADAE.ADURUComputation
If ADURN is not missing then ADURU='DAY'
MT.ADAE.TRTEMFLComputation
If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'
MT.ADAE.AOCCFLComputation
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=’Y’) within each Subject
MT.ADAE.AOCCSFLComputation
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=’Y’) within each Subject and SOC
MT.ADAE.AOCCPFLComputation
Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=’Y’) within each Subject, SOC, and PT
MT.ADAE.AOCC02FLComputation
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=’Y’) within each Subject
MT.ADAE.AOCC03FLComputation
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=’Y’) within each Subject and SOC
MT.ADAE.AOCC04FLComputation
Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=’Y’) within each Subject, SOC, and PT
MT.ADAE.CQ01NAMComputation
If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL
MT.ADAE.AOCC01FLComputation
Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=’Y’) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)

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