Date of Define-XML document generation: 2016-07-08T05:47:46-04:00

Define-XML version: 2.0.0

Stylesheet version: 2016-07-05

Standard
ADaM-IG 1.0
Study Name
CDISC-Sample
Study Description
CDISC-Sample Data Definition
Protocol Name
CDISC-Sample
Metadata Name
Data Definitions for CDISC-Sample, ADaM-IG 1.0
Metadata Description
Data Definitions for CDISC-Sample, ADaM-IG 1.0

Analysis Results Metadata - Summary

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 [page=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)

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). See page 4 (section 10.1.1) in the Statistical Analysis Plan.

Statistical Analysis Plan [page=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)

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. See page 4 (section 10.1.1) in the Statistical Analysis Plan.

Statistical Analysis Plan [page=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 [page=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)

AEBODSYS (Body System or Organ Class)

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. See page 5 (section 11.2) in the Statistical Analysis Plan.

Statistical Analysis Plan [page=5]

Programming Statements[SAS version 9.2]

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Analysis Datasets for Study CDISC-Sample (ADaM-IG 1.0)

Analysis Datasets for Study CDISC-Sample (ADaM-IG 1.0)
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADSLSubject Level AnalysisSUBJECT LEVEL ANALYSIS DATASETone record per subjectAnalysisSTUDYID, USUBJIDadsl.xpt

Screen Failures are excluded since they are not needed for this study analysis. See Analysis Data Reviewer's Guide, page 6.

Analysis Data Reviewer's Guide [page=6]

ADQSADASADAS-Cog AnalysisBASIC DATA STRUCTUREOne record per subject per parameter per analysis visit per analysis dateAnalysisSTUDYID, USUBJID, PARAMCD, AVISIT, ADTadqsadas.xpt

See referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1

Analysis Data Reviewer's Guide

adqsadas.sas

ADAEAdverse Events AnalysisOCCURRENCE DATA STRUCTUREone record per subject per adverse eventAnalysisSTUDYID, USUBJID, AETERM, ASTDT, AESEQadae.xpt

See SAS program

adae.sas

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Subject Level Analysis (ADSL)

ADSL (Subject Level Analysis) - SUBJECT LEVEL ANALYSIS DATASET [Location: adsl.xpt]
VariableLabelKeyTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
STUDYIDStudy Identifier1text12Predecessor: DM.STUDYID
USUBJIDUnique Subject Identifier2text11Predecessor: DM.USUBJID
SUBJIDSubject Identifier for the Studytext4Predecessor: DM.SUBJID
SITEIDStudy Site Identifiertext3Predecessor: DM.SITEID
SITEGR1Pooled Site Group 1text3Derived:
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)integer8Actual Treatment (N)
  • 0 = "Placebo"
  • 54 = "Xanomeline Low Dose"
  • 81 = "Xanomeline High Dose"
Assigned:

Numeric code for TRT01P which corresponds to the randomized dose

TRT01AActual Treatment for Period 01text20Actual Treatment
  • "Placebo"
  • "Xanomeline Low Dose"
  • "Xanomeline High Dose"
Assigned:

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

TRT01ANActual Treatment for Period 01 (N)integer8Actual Treatment (N)
  • 0 = "Placebo"
  • 54 = "Xanomeline Low Dose"
  • 81 = "Xanomeline High Dose"
Assigned:

Numeric code for TRT01A which corresponds to the randomized dose

TRTSDTDate of First Exposure to Treatmentintegerdate9.Derived:
SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date
TRTEDTDate of Last Exposure to Treatmentintegerdate9.Derived:
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)integer8Derived:
TRTEDT-TRTSDT+1
AVGDDAvg Daily Dose (as planned)float8Derived:
CUMDOSE/TRTDURD
CUMDOSECumulative Dose (as planned)float8Derived:
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., VISIT4DATE-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., VISIT12DATE-VISIT4DATE if 2nd interval completed, TRTEDT-VISIT4DATE 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 - VISIT12DATE if subject continued after Visit 12). Note that VISIT4DATE=SV.SVSTDTC where VISITNUM=4 and VISIT12DATE=SV.SVSTDTC where VISITNUM=12.
AGEAgeinteger8Predecessor: DM.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • "<65"
  • "65-80"
  • ">80"
Derived:
Character variable derived from ADSL.AGEGR1N
AGEGR1NPooled Age Group 1 (N)integer8Age Group (N)
  • 1 = "<65"
  • 2 = "65-80"
  • 3 = ">80"
Assigned:

AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80.

AGEUAge Unitstext5Age Unit
  • "YEARS"
Predecessor: DM.AGEU
RACERacetext32Race
  • "WHITE"
  • "BLACK OR AFRICAN AMERICAN"
  • "ASIAN"
  • "AMERICAN INDIAN OR ALASKA NATIVE"
Predecessor: DM.RACE
RACENRace (N)integer8Race (N)
  • 1 = "WHITE"
  • 2 = "BLACK OR AFRICAN AMERICAN"
  • 6 = "AMERICAN INDIAN OR ALASKA NATIVE"
  • 7 = "ASIAN"
Assigned:

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:
Y if ITTFL='Y' and TRTSDT ne missing. N otherwise
ITTFLIntent-To-Treat Population Flagtext1No Yes Response
  • "N" = "No"
  • "Y" = "Yes"
Derived:
Y if ARMCD ne ' '. N otherwise
EFFFLEfficacy Population Flagtext1No Yes Response
  • "N" = "No"
  • "Y" = "Yes"
Derived:
Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise
COMP8FLCompleters of Week 8 Population Flagtext1No Yes Response
  • "N" = "No"
  • "Y" = "Yes"
Derived:
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:
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:
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:
Y if DCSREAS ^= 'Completed'. Null otherwise
DSRAEFLSubject Discontinued due to AE Flagtext1No Yes Response - Y subset
  • "Y" = "Yes"
Derived:
Y if DCSREAS='Adverse Event'. Null otherwise
DTHFLSubject Death Flagtext1No Yes Response - Y subset
  • "Y" = "Yes"
Predecessor: DM.DTHFL
BMIBLBaseline BMI (kg/m^2)float8Derived:
WEIGHTBL / ((HEIGHTBL*100)**2)
BMIBLGR1Pooled Baseline BMI Group 1text6Body Mass Index Category
  • "<25" = "Normal"
  • "25-<30" = "Overweight"
  • ">30" = "Obese"
Derived:
BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30
HEIGHTBLBaseline Height (cm)float8Derived:
VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1
WEIGHTBLBaseline Weight (kg)float8Derived:
VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3
EDUCLVLYears of Educationinteger8Derived:
SC.SCSTRESN where SC.SCTESTCD="EDLEVEL"
DISONDTDate of Onset of Diseaseintegerdate9.Derived:
MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date
DURDISDuration of Disease (Months)float8Derived:
number of months between VISIT1DT and DISONDT
DURDSGR1Pooled Disease Duration Group 1text4Disease Duration Group
  • "<12"
  • ">=12"
Derived:
grouping DURDIS values as <12 and >=12
VISIT1DTDate of Visit 1integerdate9.Derived:
SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date
RFSTDTCSubject Reference Start Date/TimedateISO8601Predecessor: DM.RFSTDTC
RFENDTCSubject Reference End Date/TimedateISO8601Predecessor: DM.RFENDTC
VISNUMENEnd of Trt Visit (Vis 12 or Early Term.)integer8Derived:
if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'
RFENDTDate of Discontinuation/Completioninteger8Derived:
RFENDTC converted to SAS date
DCDECODStandardized Disposition Termtext27Completion/Reason for Non-Completion

[9 Terms]

Derived:
DS.DSDECOD where DSCAT='DISPOSITION EVENT'
DCSREASReason for Discontinuation from Studytext18Reason for Discontinuation

[10 Terms]

Derived:
Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation
MMSETOTMMSE Totalinteger8Derived:
Sum of QS.QSORRES values where QS.QSCAT="MINI-MENTAL STATE" for the subject

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ADAS-Cog Analysis (ADQSADAS)

ADQSADAS (ADAS-Cog Analysis) - BASIC DATA STRUCTURE [Location: adqsadas.xpt]
VariableLabelKeyTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
STUDYIDStudy Identifier1text12Predecessor: ADSL.STUDYID
SITEIDStudy Site Identifiertext3Predecessor: ADSL.SITEID
SITEGR1Pooled Site Group 1text3Predecessor: ADSL.SITEGR1
USUBJIDUnique Subject Identifier2text11Predecessor: 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)integer8Actual Treatment (N)
  • 0 = "Placebo"
  • 54 = "Xanomeline Low Dose"
  • 81 = "Xanomeline High Dose"
Predecessor: ADSL.TRT01PN
AGEAgeinteger8Predecessor: ADSL.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • "<65"
  • "65-80"
  • ">80"
Predecessor: ADSL.AGEGR1
AGEGR1NPooled Age Group 1 (N)integer8Age 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)integer8Race (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 Visit4text16Analysis Visit
  • "Baseline"
  • "Week 8"
  • "Week 16"
  • "Week 24"
Derived:
Derived based on windowing algorithm described in SAP, Section 8.2
AVISITNAnalysis Visit (N)integer8Analysis Visit (N)
  • 0 = "Baseline"
  • 8 = "Week 8"
  • 16 = "Week 16"
  • 24 = "Week 24"
Assigned:

Numeric code for AVISIT

VISITVisit Nametext19Visit

[37 Terms]

Predecessor: QS.VISIT
VISITNUMVisit Numberfloat8Visit Number

[37 Terms]

Predecessor: QS.VISITNUM
ADYAnalysis Relative Dayinteger8Derived:
ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT.
ADTAnalysis Date5integerdate9.Derived:
SAS date from QS.QSDTC
PARAMParametertext100ADAS-Cog Parameter

[15 Terms]

Assigned:
PARAMCDParameter Code3text8ADAS-Cog Parameter Code

[15 Terms]

Assigned:
PARAMNParameter (N)integer8ADAS-Cog Parameter Code (N)

[15 Terms]

Assigned:

Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS)

AVALAnalysis Valueinteger8
Derivations are described per parameter in the parameter value level metadata
BASEBaseline Valueinteger8Derived:
QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)
CHGChange from Baselineinteger8Derived:
AVAL - BASE
PCHGPercent Change from Baselineinteger8Derived:
100* (CHG/BASE)
ABLFLBaseline Record Flagtext1No Yes Response - Y subset
  • "Y" = "Yes"
Predecessor: QS.QSBLFL
ANL01FLAnalysis Record Flag 01text1No Yes Response - Y subset
  • "Y" = "Yes"
Derived:
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".
DTYPEDerivation Typetext7Derivation Type
  • "LOCF" = "Last Observation Carried Forward"
AWRANGEAnalysis Window Valid Relative Rangetext9Assigned:

Window range, specified in the SAP.

AWTARGETAnalysis Window Targetinteger8Assigned:

Target day within the window, specified in the SAP.

AWTDIFFAnalysis Window Diff from Targetinteger8Derived:
Absolute difference between AWTARGET and ADY
AWLOAnalysis Window Beginning Timepointinteger8Assigned:

Start day of the window, specified in the SAP.

AWHIAnalysis Window Ending Timepointinteger8Assigned:

End day of the window, specified in the SAP.

AWUAnalysis Window Unittext4Unit - AWU
  • "DAYS"
Assigned:

Assigned as "DAYS".

QSSEQSequence Numberinteger8

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Adverse Events Analysis (ADAE)

ADAE (Adverse Events Analysis) - OCCURRENCE DATA STRUCTURE [Location: adae.xpt]
VariableLabelKeyTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
STUDYIDStudy Identifier1text12Predecessor: ADSL.STUDYID
SITEIDStudy Site Identifiertext3Predecessor: ADSL.SITEID
USUBJIDUnique Subject Identifier2text11Predecessor: ADSL.USUBJID
TRTAActual Treatmenttext20Actual Treatment
  • "Placebo"
  • "Xanomeline Low Dose"
  • "Xanomeline High Dose"
Predecessor: ADSL.TRT01A
TRTANActual Treatment (N)integer8Actual Treatment (N)
  • 0 = "Placebo"
  • 54 = "Xanomeline Low Dose"
  • 81 = "Xanomeline High Dose"
Predecessor: ADSL.TRT01AN
AGEAgeinteger8Predecessor: ADSL.AGE
AGEGR1Pooled Age Group 1text5Age Group
  • "<65"
  • "65-80"
  • ">80"
Predecessor: ADSL.AGEGR1
AGEGR1NPooled Age Group 1 (N)integer8Age 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)integer8Race (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 Date4integerdate9.Derived:
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:
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 Dayinteger8Derived:
IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT
AENDTAnalysis End Dateintegerdate9.Derived:
AE.AEENDTC, converted to a numeric SAS date
AENDYAnalysis End Relative Dayinteger8Derived:
IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT
ADURNAE Duration (N)integer8Derived:
ADURN=AENDT-ASTDT+1
ADURUAE Duration Unitstext3Derived:
If ADURN is not missing then ADURU='DAY'
AETERMReported Term for the Adverse Event3text46Predecessor: AE.AETERM
AELLTLowest Level Termtext46Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AELLT
AELLTCDLowest Level Term Codeinteger8Predecessor: AE.AELLTCD
AEDECODDictionary-Derived Termtext46Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEDECOD
AEPTCDPreferred Term Codeinteger8Predecessor: AE.AEPTCD
AEHLTHigh Level Termtext8Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEHLT
AEHLTCDHigh Level Term Codeinteger8Predecessor: AE.AEHLTCD
AEHLGTHigh Level Group Termtext9Adverse Event Dictionary

MedDRA 8.0

Predecessor: AE.AEHLGT
AEHLGTCDHigh Level Group Term Codeinteger8Predecessor: 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 Codeinteger8Predecessor: 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 Treatmenttext1Predecessor: AE.AEACN
AEOUTOutcome of Adverse Eventtext26Outcome of Adverse Event
  • "RECOVERED/RESOLVED"
  • "NOT RECOVERED/NOT RESOLVED"
  • "FATAL"
Predecessor: AE.AEOUT
AESEQSequence Number5integer8Predecessor: AE.AESEQ
TRTEMFLTreatment Emergent Analysis Flagtext1No Yes Response
  • "N" = "No"
  • "Y" = "Yes"
Derived:
If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'
AOCCFL1st Occurrence of Any AE Flagtext1No Yes Response - Y subset
  • "Y" = "Yes"
Derived:
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:
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:
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:
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:
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:
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 Nametext19Derived:
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:
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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Parameter Value Lists

Parameter Value List - ADQSADAS [AVAL]
VariableWhereTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
AVALPARAMCD 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)
)
integer8Derived:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVALPARAMCD = "ACTOT" (Adas-Cog(11) Subscore)
integer8Derived:
Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see Analysis Data Reviewers Guide (Page 3) for details on adjusting for missing values.

Analysis Data Reviewer's Guide [page=3]

Parameter Value List - ADQSADAS [DTYPE]
VariableWhereTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
DTYPEPARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore)
text7Derivation Type
  • "LOCF" = "Last Observation Carried Forward"
Assigned:

Value: null

DTYPEPARAMCD = "ACTOT" (Adas-Cog(11) Subscore)
text7Derivation Type
  • "LOCF" = "Last Observation Carried Forward"
Assigned:

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

Parameter Value List - ADQSADAS [QSSEQ]
VariableWhereTypeLength or Display FormatControlled Terms or FormatSource / Derivation / Comment
QSSEQPARAMCD ≠ "ACTOT" (Adas-Cog(11) Subscore)
integer8Predecessor: QS.QSSEQ
QSSEQPARAMCD = "ACTOT" (Adas-Cog(11) Subscore)
integer8Assigned:

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

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Controlled Terms

Causality [CL.AECAUS]
Permitted Value (Code)
NONE
POSSIBLE
PROBABLE
REMOTE
Severity/Intensity Scale for Adverse Events [CL.AESEV, C66769]
Permitted Value (Code)Display Value (Decode)
MILD [C41338]Grade 1
MODERATE [C41339]Grade 2
SEVERE [C41340]Grade 3
Age Group [CL.AGEGR1]
Permitted Value (Code)
<65
65-80
>80
Age Group (N) [CL.AGEGR1N]
Permitted Value (Code)Display Value (Decode)
1<65
265-80
3>80
Age Unit [CL.AGEU, C66781]
Permitted Value (Code)
YEARS [C29848]
Actual Treatment [CL.ARM]
Permitted Value (Code)
Placebo
Xanomeline Low Dose
Xanomeline High Dose
Actual Treatment (N) [CL.ARMN]
Permitted Value (Code)Display Value (Decode)
0Placebo
54Xanomeline Low Dose
81Xanomeline High Dose
Analysis Visit [CL.AVISIT]
Permitted Value (Code)
Baseline
Week 8
Week 16
Week 24
Analysis Visit (N) [CL.AVISITN]
Permitted Value (Code)Display Value (Decode)
0Baseline
8Week 8
16Week 16
24Week 24
Unit - AWU [CL.AWU, C71620]
Permitted Value (Code)
DAYS [C25301]
Body Mass Index Category [CL.BMICAT]
Permitted Value (Code)Display Value (Decode)
<25Normal
25-<30Overweight
>30Obese
Date Imputation Flag [CL.DATEFL, C81223]
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 [CL.DISCCD, C66727]
Permitted Value (Code)
COMPLETED [C25250]
ADVERSE EVENT [C41331]
DEATH [C28554]
LACK OF EFFICACY [C48226]
LOST TO FOLLOW-UP [C48227]
PHYSICIAN DECISION [C48250]
PROTOCOL VIOLATION [C48251]
STUDY TERMINATED BY SPONSOR [C49632]
WITHDRAWAL BY SUBJECT [C49634]
Reason for Discontinuation [CL.DISCREAS]
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 [CL.DTYPE, C81224]
Permitted Value (Code)Display Value (Decode)
LOCF [C81198]Last Observation Carried Forward
Disease Duration Group [CL.DURDISC]
Permitted Value (Code)
<12
>=12
Ethnic Group [CL.ETHNIC, C66790]
Permitted Value (Code)
HISPANIC OR LATINO [C17459]
NOT HISPANIC OR LATINO [C41222]
Outcome of Adverse Event [CL.OUT, C66768]
Permitted Value (Code)
RECOVERED/RESOLVED [C49498]
NOT RECOVERED/NOT RESOLVED [C49494]
FATAL [C48275]
ADAS-Cog Parameter Code [CL.PARAMCD_ADQSADAS]
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) [CL.PARAMN_ADQSADAS]
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 [CL.PARAM_ADQSADAS]
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
Race [CL.RACE, C74457]
Permitted Value (Code)
WHITE [C41261]
BLACK OR AFRICAN AMERICAN [C16352]
ASIAN [C41260]
AMERICAN INDIAN OR ALASKA NATIVE [C41259]
Race (N) [CL.RACEN]
Permitted Value (Code)Display Value (Decode)
1WHITE
2BLACK OR AFRICAN AMERICAN
6AMERICAN INDIAN OR ALASKA NATIVE
7ASIAN
Sex [CL.SEX, C66731]
Permitted Value (Code)Display Value (Decode)
F [C16576]Female
M [C20197]Male
U [C17998]Unknown
Visit [CL.VISIT]
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 [CL.VISITNUM]
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 [CL.YN, C66742]
Permitted Value (Code)Display Value (Decode)
N [C49487]No
Y [C49488]Yes
No Yes Response - Y subset [CL.Y_BLANK, C66742]
Permitted Value (Code)Display Value (Decode)
Y [C49488]Yes

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External Dictionaries

External Dictionaries
Reference NameExternal DictionaryDictionary Version
Adverse Event Dictionary (CL.AEDICT) MedDRA8.0

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Analysis Derivations

Analysis Derivations
MethodTypeDescription
MT.ADAE.ADURNComputation
ADURN=AENDT-ASTDT+1
MT.ADAE.ADURUComputation
If ADURN is not missing then ADURU='DAY'
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.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)
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.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.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.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.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.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.TRTEMFLComputation
If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'
MT.ADQSADAS.ADTComputation
SAS date from QS.QSDTC
MT.ADQSADAS.ADYComputation
ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT.
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.AVALComputation
Derivations are described per parameter in the parameter value level metadata
MT.ADQSADAS.AVISITComputation
Derived based on windowing algorithm described in SAP, Section 8.2
MT.ADQSADAS.AWTDIFFComputation
Absolute difference between AWTARGET and ADY
MT.ADQSADAS.BASEComputation
QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)
MT.ADQSADAS.CHGComputation
AVAL - BASE
MT.ADQSADAS.PCHGComputation
100* (CHG/BASE)
MT.ADSL.AGEGR1Computation
Character variable derived from ADSL.AGEGR1N
MT.ADSL.AVGDDComputation
CUMDOSE/TRTDURD
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.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.COMP8FLComputation
Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise
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., VISIT4DATE-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., VISIT12DATE-VISIT4DATE if 2nd interval completed, TRTEDT-VISIT4DATE 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 - VISIT12DATE if subject continued after Visit 12). Note that VISIT4DATE=SV.SVSTDTC where VISITNUM=4 and VISIT12DATE=SV.SVSTDTC where VISITNUM=12.
MT.ADSL.DCDECODComputation
DS.DSDECOD where DSCAT='DISPOSITION EVENT'
MT.ADSL.DCSREASComputation
Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation
MT.ADSL.DISCONFLComputation
Y if DCSREAS ^= 'Completed'. Null otherwise
MT.ADSL.DISONDTComputation
MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date
MT.ADSL.DSRAEFLComputation
Y if DCSREAS='Adverse Event'. Null otherwise
MT.ADSL.DURDISComputation
number of months between VISIT1DT and DISONDT
MT.ADSL.DURDSGR1Computation
grouping DURDIS values as <12 and >=12
MT.ADSL.EDUCLVLComputation
SC.SCSTRESN where SC.SCTESTCD="EDLEVEL"
MT.ADSL.EFFFLComputation
Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise
MT.ADSL.HEIGHTBLComputation
VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1
MT.ADSL.ITTFLComputation
Y if ARMCD ne ' '. N otherwise
MT.ADSL.MMSETOTComputation
Sum of QS.QSORRES values where QS.QSCAT="MINI-MENTAL STATE" for the subject
MT.ADSL.RFENDTComputation
RFENDTC converted to SAS date
MT.ADSL.SAFFLComputation
Y if ITTFL='Y' and TRTSDT ne missing. N otherwise
MT.ADSL.SITEGR1Computation
refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900
MT.ADSL.TRTDURDComputation
TRTEDT-TRTSDT+1
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.TRTSDTComputation
SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date
MT.ADSL.VISIT1DTComputation
SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date
MT.ADSL.VISNUMENComputation
if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'
MT.ADSL.WEIGHTBLComputation
VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3
MT.ADQSADAS.AVAL.WC.ADQSADAS.AVAL.00001Computation
Sum of ADAS scores for items 1, 2, 4, 5, 6, 7, 8, 11, 12, 13, and 14, see Analysis Data Reviewers Guide (Page 3) for details on adjusting for missing values.

Analysis Data Reviewer's Guide [page=3]

MT.ADQSADAS.AVAL.WC.ADQSADAS.AVAL.00002Computation
QS.QSSTRESN where QSTESTCD=PARAMCD

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Comments

Comments
CommentOIDDescription
COM.ADAESee SAS program

adae.sas

COM.ADQSADASSee referenced dataset creation program and Analysis Data Reviewer's Guide, Section 2.1

Analysis Data Reviewer's Guide

adqsadas.sas

COM.ADSLScreen Failures are excluded since they are not needed for this study analysis. See Analysis Data Reviewer's Guide, page 6.

Analysis Data Reviewer's Guide [page=6]

COM.ADQSADAS.AVISITNNumeric code for AVISIT
COM.ADQSADAS.AWHIEnd day of the window, specified in the SAP.
COM.ADQSADAS.AWLOStart day of the window, specified in the SAP.
COM.ADQSADAS.AWRANGEWindow range, specified in the SAP.
COM.ADQSADAS.AWTARGETTarget day within the window, specified in the SAP.
COM.ADQSADAS.AWUAssigned as "DAYS".
COM.ADQSADAS.PARAMNAssign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS)
COM.ADSL.AGEGR1NAGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80.
COM.ADSL.RACENNumeric code for RACE
COM.ADSL.TRT01ATRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.
COM.ADSL.TRT01ANNumeric code for TRT01A which corresponds to the randomized dose
COM.ADSL.TRT01PNNumeric code for TRT01P which corresponds to the randomized dose
COM.ADQSADAS.DTYPE.WC.ADQSADAS.DTYPE.00003Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit.
COM.ADQSADAS.DTYPE.WC.ADQSADAS.DTYPE.00004Value: null
COM.ADQSADAS.QSSEQ.WC.ADQSADAS.QSSEQ.00005Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT.
COM.ARM.AR.Table_14-5.02.R.1Get 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.

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