CDISC-Sample CDISC-Sample Data Definition CDISC-Sample ACITM01 ACITM02 ACITM03 ACITM04 ACITM05 ACITM06 ACITM07 ACITM08 ACITM09 ACITM10 ACITM11 ACITM12 ACITM13 ACITM14 ACTOT ACTOT ACTOT ACTOT ACTOT ACTOT Week 24 Y Y ACTOT Week 24 Y Y Y Y Y Subject-Level Analysis adsl.xpt ADAS-Cog Analysis adqsadas.xpt Adverse Events Analysis Dataset adae.xpt Study Identifier ADSL.STUDYID Study Site Identifier ADSL.SITEID Pooled Site Group 1 ADSL.SITEGR1 Unique Subject Identifier ADSL.USUBJID Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Planned Treatment ADSL.TRT01P Planned Treatment (N) ADSL.TRT01PN Age ADSL.AGE Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Race ADSL.RACE Race (N) ADSL.RACEN Sex ADSL.SEX Intent-To-Treat Population Flag ADSL.ITTFL Efficacy Population Flag ADSL.FASFL Completers of Week 24 Population Flag ADSL.COMP24FL Analysis Visit Analysis Visit (N) Visit Name QS.VISIT Visit Number QS.VISITNUM Analysis Relative Day Analysis Date Parameter Parameter Code Parameter (N) Analysis Value Baseline Value Change from Baseline Percent Change from Baseline Baseline Record Flag QS.QSBLFL Analysis Flag 01 Derivation Type Analysis Window Valid Relative Range Analysis Window Target Analysis Window Diff from Target Analysis Window Beginning Timepoint Analysis Window Ending Timepoint Analysis Window Unit Sequence Number Study Identifier DM.STUDYID Unique Subject Identifier DM.USUBJID Subject Identifier for the Study DM.SUBJID Study Site Identifier DM.SITEID Pooled Site Group 1 Description of Planned Arm DM.ARM Planned Treatment for Period 01 DM.ARM Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Date of First Exposure to Treatment Date of Last Exposure to Treatment Total Treatment Duration (Days) Avg Daily Dose (as planned) Cumulative Dose (as planned) Age DM.AGE Pooled Age Group 1 Pooled Age Group 1 (N) Age Units DM.AGEU Race DM.RACE Race (N) Sex DM.SEX Ethnicity DM.ETHNIC Safety Population Flag Intent-To-Treat Population Flag Efficacy Population Flag Completers of Week 8 Population Flag Completers of Week 16 Population Flag Completers of Week 24 Population Flag Subject Discontinued Study Flag Subject Discontinued due to AE Flag Subject Death Flag DM.DTHFL Baseline BMI (kg/m^2) Pooled Baseline BMI Group 1 Baseline Height (cm) Baseline Weight (kg) Years of Education Date of Onset of Disease Duration of Disease (Months) Pooled Disease Duration Group 1 Date of Visit 1 Subject Reference Start Date/Time DM.RFSTDTC Subject Reference End Date/Time DM.RFENDTC End of Trt Visit (Vis 12 or Early Term.) Date of Discontinuation/Completion End of Study Status Reason for Discontinuation from Study Standardized Disposition Term DS.DSDECOD where DS.DSCAT='DISPOSITION EVENT' MMS1-Total Score at Baseline Analysis Value QS.QSSTRESN where QS.QSTESTCD=ADQSADAS.PARAMCD Analysis Value Derivation Type Derivation Type Sequence Number QS.QSSEQ Sequence Number Study Identifier ADSL.STUDYID Study Site Identifier ADSL.SITEID Unique Subject Identifier ADSL.USUBJID Actual Treatment ADSL.TRT01A Actual Treatment (N) ADSL.TRT01AN Age ADSL.AGE Pooled Age Group 1 ADSL.AGEGR1 Pooled Age Group 1 (N) ADSL.AGEGR1N Race ADSL.RACE Race (N) ADSL.RACEN Sex ADSL.SEX Safety Population Flag ADSL.SAFFL Date of First Exposure to Treatment ADSL.TRTSDT Date of Last Exposure to Treatment ADSL.TRTEDT Analysis Start Date Analysis Start Date Imputation Flag Analysis Start Relative Day Analysis End Date Analysis End Relative Day Analysis Duration (N) Analysis Duration Units Reported Term for the Adverse Event AE.AETERM Lowest Level Term AE.AELLT Lowest Level Term Code AE.AELLTCD Dictionary-Derived Term AE.AEDECOD Preferred Term Code AE.AEPTCD High Level Term AE.AEHLT High Level Term Code AE.AEHLTCD High Level Group Term AE.AEHLGT High Level Group Term Code AE.AEHLGTCD Body System or Organ Class AE.AEBODSYS Primary System Organ Class AE.AESOC Primary System Organ Class Code AE.AESOCCD Severity/Intensity AE.AESEV Serious Event AE.AESER Involves Cancer AE.AESCAN Congenital Anomaly or Birth Defect AE.AESCONG Persist or Signif Disability/Incapacity AE.AESDISAB Results in Death AE.AESDTH Requires or Prolongs Hospitalization AE.AESHOSP Is Life Threatening AE.AESLIFE Occurred with Overdose AE.AESOD Causality AE.AEREL Action Taken with Study Treatment AE.AEACN Outcome of Adverse Event AE.AEOUT Sequence Number AE.AESEQ Treatment Emergent Analysis Flag 1st Occurrence within Subject Flag 1st Occurrence of SOC Flag 1st Occurrence of Preferred Term Flag 1st Occurrence of Serious 02 Flag 1st Occurrence of Serious SOC 03 Flag 1st Occurrence of Serious PT 04 Flag Customized Query 01 Name 1st Occurrence of CQ01 01 Flag <65 65-80 >80 Placebo Xanomeline Low Dose Xanomeline High Dose Baseline Week 8 Week 16 Week 24 Normal Overweight Obese Day Imputed: Day is imputed Month Imputed: Month and day are imputed Year Imputed: Entire date (year, month and day) is imputed Last Observation Carried Forward 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 Speech Recall Of Test Instructions Adas-Cog(11) Subscore 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 WHITE BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE ASIAN Female Male Unknown 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 No Yes Yes Grade 1 Grade 2 Grade 3 Derived based on windowing algorithm described in SAP, Section 8.2 ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY = ADT - TRTSDT, if ADT<TRTSDT. SAS date from QS.QSDTC QS.QSSTRESN where QS.QSBLFL=Y (QS.VISITNUM=3) AVAL - BASE 100* (CHG/BASE) 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". Absolute difference between AWTARGET and ADY refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900 SV.SVSTDTC where SV.VISITNUM=3, converted to SAS date 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. TRTEDT-TRTSDT+1 CUMDOSE/TRTDURD 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). Grouping of AGE into <65, 65-80, and >80 Y if ITTFL='Y' and TRTSDT ne missing. N otherwise Y if ARMCD ne ' '. N otherwise 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 Y if subject has a SV.VISITNUM=8 and TRTEDT>= date of visit 8, N otherwise Y if subject has a SV.VISITNUM=10 and TRTEDT>=date of visit 10, N otherwise Y if subject has a SV.VISITNUM=12 and TRTEDT>= date of visit 12 , N otherwise Y if EOSSTT='DISCONTINUED'. Null otherwise Y if DCSREAS='Adverse Event'. Null otherwise WEIGHTBL / ((HEIGHTBL*100)**2) BMIBLGR1=Normal if . < BMIBL <25. BMIBLGR1=Overweight if 25 <=BMIBL <30. BMIBLGR1=Obese if BMIBL >=30 VS.VSSTRESN where VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1 VS.VSSTRESN where VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3 SC.SCSTRESN where SC.SCTESTCD="EDLEVEL" MH.MHSTDTC where MH.MHCAT='PRIMARY DIAGNOSIS' converted to SAS date number of months between Date of VISIT 1 and DISONDT grouping DURDIS values as <12 and >=12 SV.SVSTDTC where SV.VISITNUM=1, converted to SAS date If DS.VISITNUM=13 where DS.DSTERM='PROTOCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DS.DSTERM='PROTOCOL COMPLETED' RFENDTC converted to SAS date If DS.DSDECOD='COMPLETED' then EOSSTT='COMPLETED'. Otherwise EOSSTT='DISCONTINUED'. 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. Sum of FT.FTSTRESN values where FT.FTCAT="MMSE" for the subject (FT.FTTESTCD= 'MMS101A'-'MMS111') 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. 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. ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT AE.AEENDTC, converted to a numeric SAS date IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT ADURN=AENDT-ASTDT+1 If ADURN is not missing then ADURU='DAY' If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N' 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 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 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 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 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 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 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 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) Screen Failures are excluded since they are not needed for this study analysis. See referenced dataset creation program and ADRG See SAS program See referenced dataset creation program and ADRG 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. Numeric code for AVISIT Numeric code for PARAM Window range, specified in the SAP. Target day within the window, specified in the SAP. Start day of the window, specified in the SAP. End day of the window, specified in the SAP. Assigned as "DAYS". Numeric code for TRT01P TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study. Numeric code for TRT01A Numeric code for AGEGR1 Numeric code for RACE Value: null Value: LOCF denotes that the LOCF imputation method was used to impute the value for the given parameter and analysis visit. Set QSSEQ to missing for post baseline records. Set to QS.QSSEQ where QS.VISIT=BASELINE and QS.QSTESTCD=ACTOT. ADaM specific CT is applicable for a few variables only. SDTM CT is applicable for variables copied from SDTM to ADaM. This is the CDISC CT Package 61 (2026-03-27) associated to the CDISC Define-XML Specification Version 2.1.11. Analysis Data Reviewer's Guide adqsadas.sas adae.sas adsl.sas Clinical Study Report at14-5-02.sas Primary Endpoint Analysis: ADAS-Cog - Summary at Week 24 - LOCF (Efficacy Population) Dose response analysis for ADAS-Cog changes from baseline Linear 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). proc glm data = ADQSADAS; where EFFFL='Y' and ANL01FL='Y' and AVISIT='Week 24' and PARAMCD="ACTOT"; class SITEGR1; model CHG = TRTPN SITEGR1; run; Pairwise comparisons to placebo for ADAS-Cog changes from baseline ANCOVA 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. 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; Incidence of Treatment Emergent Serious Adverse Events by Treatment Group Incidence of Treatment Emergent Serious Adverse Events by Treatment Group Unique 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.