├── CDISC.Pilot Project Data.Website Disclaimer.v1.pdf
├── README.md
├── reference-ranges
└── lab1_0_1refrangesampledata.xpt
├── sdtmadampilotprojectreport.pdf
└── updated-pilot-submission-package
└── 900172
├── m1
├── m1toc.pdf
└── us
│ └── 12-cov-let
│ └── cover.pdf
├── m5
├── 53-clin-stud-rep
│ └── 535-rep-effic-safety-stud
│ │ └── 5351-stud-rep-contr
│ │ └── cdiscpilot01
│ │ ├── cdiscpilot01.pdf
│ │ └── narratives.txt
├── datasets
│ ├── cdiscpilot01
│ │ ├── analysis
│ │ │ └── adam
│ │ │ │ ├── datasets
│ │ │ │ ├── adae.json
│ │ │ │ ├── adae.xpt
│ │ │ │ ├── adlbc.json
│ │ │ │ ├── adlbc.xpt
│ │ │ │ ├── adlbh.json
│ │ │ │ ├── adlbh.xpt
│ │ │ │ ├── adlbhy.json
│ │ │ │ ├── adlbhy.xpt
│ │ │ │ ├── adqsadas.json
│ │ │ │ ├── adqsadas.xpt
│ │ │ │ ├── adqscibc.json
│ │ │ │ ├── adqscibc.xpt
│ │ │ │ ├── adqsnpix.json
│ │ │ │ ├── adqsnpix.xpt
│ │ │ │ ├── adsl.json
│ │ │ │ ├── adsl.xpt
│ │ │ │ ├── adtte.json
│ │ │ │ ├── adtte.xpt
│ │ │ │ ├── advs.json
│ │ │ │ ├── advs.xpt
│ │ │ │ ├── dataguide.pdf
│ │ │ │ ├── define-v1-updated-html.xsl
│ │ │ │ ├── define.html
│ │ │ │ ├── define.pdf
│ │ │ │ └── define.xml
│ │ │ │ └── programs
│ │ │ │ ├── adae.sas
│ │ │ │ └── at14-5-02.sas
│ │ └── tabulations
│ │ │ └── sdtm
│ │ │ ├── ae.json
│ │ │ ├── ae.xpt
│ │ │ ├── blankcrf.pdf
│ │ │ ├── cm.json
│ │ │ ├── cm.xpt
│ │ │ ├── define-v1-updated-html.xsl
│ │ │ ├── define.html
│ │ │ ├── define.pdf
│ │ │ ├── define.xml
│ │ │ ├── dm.json
│ │ │ ├── dm.xpt
│ │ │ ├── ds.json
│ │ │ ├── ds.xpt
│ │ │ ├── ex.json
│ │ │ ├── ex.xpt
│ │ │ ├── lb.json
│ │ │ ├── lb.xpt
│ │ │ ├── mh.json
│ │ │ ├── mh.xpt
│ │ │ ├── qs.json
│ │ │ ├── qs.xpt
│ │ │ ├── relrec.json
│ │ │ ├── relrec.xpt
│ │ │ ├── sc.json
│ │ │ ├── sc.xpt
│ │ │ ├── se.json
│ │ │ ├── se.xpt
│ │ │ ├── suppae.json
│ │ │ ├── suppae.xpt
│ │ │ ├── suppdm.json
│ │ │ ├── suppdm.xpt
│ │ │ ├── suppds.json
│ │ │ ├── suppds.xpt
│ │ │ ├── supplb.json
│ │ │ ├── supplb.xpt
│ │ │ ├── sv.json
│ │ │ ├── sv.xpt
│ │ │ ├── ta.json
│ │ │ ├── ta.xpt
│ │ │ ├── te.json
│ │ │ ├── te.xpt
│ │ │ ├── ti.json
│ │ │ ├── ti.xpt
│ │ │ ├── ts.json
│ │ │ ├── ts.xpt
│ │ │ ├── tv.json
│ │ │ ├── tv.xpt
│ │ │ ├── vs.json
│ │ │ └── vs.xpt
│ └── datatoc.pdf
└── m5toc.pdf
└── ndatoc.pdf
/CDISC.Pilot Project Data.Website Disclaimer.v1.pdf:
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https://raw.githubusercontent.com/cdisc-org/sdtm-adam-pilot-project/667511d4b183871d74392ba691c935c38d431d39/CDISC.Pilot Project Data.Website Disclaimer.v1.pdf
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/README.md:
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1 | # DISCLAIMER AND LIABILITY
2 | This website provides clinical test data for informational purposes and the convenience of the public. CDISC does not control or guarantee the currency, accuracy, relevance, or completeness of the data. The data has been analyzed, cleansed, and aggregated where appropriate to facilitate use and discussion in research. By downloading / using this data, you agree to the Terms of use.
3 |
4 | ## Terms of Use
5 |
6 | You shall not (and will not allow or assist any third party to), under any circumstances: (i) mislead, confuse, or cause misapprehension or confusion among users of the data as to the features, functionality, origin, capabilities, or other aspects of the data, (b) disassemble, reverse engineer, decompile, modify, or alter any part of the Data; (c) use the Data in any manner or for any purpose that violates any law or regulation, (d) use the Data in order to compete with CDISC, (e) sublicense or distribute the data for a fee, or (f) sublicense or distribute the data without an attribution back to CDISC.
7 |
8 | UNLESS REQUIRED BY APPLICABLE LAW, ACCESS AND USE OF THE DATA IS PROVIDED BY CDISC AND ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO THE CDISC BOARD OF DIRECTORS, CDISC EMPLOYEES, AND CDISC MEMBERS, PARTICIPANTS, CONTRACTORS, AND REPRESENTATIVES) "AS IS" AND WITHOUT ANY WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND CDISC AND ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO THE CDISC BOARD OF DIRECTORS, CDISC EMPLOYEES, AND CDISC MEMBERS, PARTICIPANTS, CONTRACTORS, AND REPRESENTATIVES) EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, TITLE, NONINFRINGEMENT, FITNESS FOR A PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF THIS LETTER AGREEMENT, INCLUDING ACCESS OR USE OF THE DATA. You are solely responsible for determining the appropriateness of accessing and/or using the data and assume any risks associated with your access and/or use.
9 |
10 | IN NO EVENT AND UNDER NO LEGAL THEORY, WHETHER IN TORT (INCLUDING NEGLIGENCE), CONTRACT, OR OTHERWISE, UNLESS REQUIRED BY APPLICABLE LAW (SUCH AS DELIBERATE AND GROSSLY NEGLIGENT ACTS) OR AGREED TO IN WRITING, SHALL CDISC, ANY OF CDISC’S CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO THE CDISC BOARD OF DIRECTORS, THE CDISC EMPLOYEES, OR CDISC MEMBERS, PARTICIPANTS, CONTRACTORS, OR REPRESENTATIVES) BE LIABLE FOR DAMAGES, INCLUDING ANY DIRECT, INDIRECT, SPECIAL, EXEMPLARY, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY CHARACTER ARISING IN ANY WAY AS A RESULT OF THIS LETTER AGREEMENT OR OUT OF THE USE OR INABILITY TO USE THE DATA (INCLUDING DAMAGES FOR LOSS OF GOODWILL, LOSS OF PROFITS, LOSS OF USE, OR BUSINESS INTERRUPTION), EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION OF DAMAGES AND CLAIMS IS INTENDED TO APPLY TO ALL CLAIMS WITHOUT REGARD TO WHICH OTHER PROVISIONS OF THIS LETTER AGREEMENT HAVE BEEN BREACHED OR PROVEN INEFFECTIVE.
11 |
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/reference-ranges/lab1_0_1refrangesampledata.xpt:
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1 |
2 |
3 | 404 Not Found
4 |
5 |
6 | Not Found
7 | The requested document was not found on this server.
8 |
9 |
10 |
11 | Web Server at cdisc.org
12 |
13 |
14 |
15 |
16 |
33 |
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/sdtmadampilotprojectreport.pdf:
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/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/analysis/adam/datasets/adae.xpt:
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/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/analysis/adam/datasets/adtte.json:
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1 | {"datasetJSONCreationDateTime":"2024-12-18T15:34:33","datasetJSONVersion":"1.1.0","fileOID":"CDISCPILOT01.adtte","dbLastModifiedDateTime":"2012-10-15T22:56:22","originator":"CDISC Data Exchange Standards Team","sourceSystem":{"name":"SAS on X64_10PRO","version":"9.0401M7"},"studyOID":"CDISCPILOT01","metaDataVersionOID":"CDISC.ADaM.2.1","metaDataRef":"define.xml","itemGroupOID":"ADTTE","records":254,"name":"ADTTE","label":"AE Time To 1st Derm. Event Analysis","columns":[{"itemOID":"ADTTE.STUDYID","name":"STUDYID","label":"Study Identifier","dataType":"string","length":12},{"itemOID":"ADTTE.SITEID","name":"SITEID","label":"Study Site Identifier","dataType":"string","length":3},{"itemOID":"ADTTE.USUBJID","name":"USUBJID","label":"Unique Subject Identifier","dataType":"string","length":11,"keySequence":1},{"itemOID":"ADTTE.AGE","name":"AGE","label":"Age","dataType":"integer"},{"itemOID":"ADTTE.AGEGR1","name":"AGEGR1","label":"Pooled Age Group 1","dataType":"string","length":5},{"itemOID":"ADTTE.AGEGR1N","name":"AGEGR1N","label":"Pooled Age Group 1 (N)","dataType":"integer"},{"itemOID":"ADTTE.RACE","name":"RACE","label":"Race","dataType":"string","length":32},{"itemOID":"ADTTE.RACEN","name":"RACEN","label":"Race (N)","dataType":"integer"},{"itemOID":"ADTTE.SEX","name":"SEX","label":"Sex","dataType":"string","length":1},{"itemOID":"ADTTE.TRTSDT","name":"TRTSDT","label":"Date of First Exposure to Treatment","dataType":"date","targetDataType":"integer","displayFormat":"DATE9."},{"itemOID":"ADTTE.TRTEDT","name":"TRTEDT","label":"Date of Last Exposure to Treatment","dataType":"date","targetDataType":"integer","displayFormat":"DATE9."},{"itemOID":"ADTTE.TRTDUR","name":"TRTDUR","label":"Duration of treatment (days)","dataType":"integer"},{"itemOID":"ADTTE.TRTP","name":"TRTP","label":"Planned Treatment","dataType":"string","length":20},{"itemOID":"ADTTE.TRTA","name":"TRTA","label":"Actual Treatment","dataType":"string","length":20},{"itemOID":"ADTTE.TRTAN","name":"TRTAN","label":"Actual Treatment (N)","dataType":"integer"},{"itemOID":"ADTTE.PARAM","name":"PARAM","label":"Parameter Description","dataType":"string","length":100},{"itemOID":"ADTTE.PARAMCD","name":"PARAMCD","label":"Parameter Code","dataType":"string","length":8,"keySequence":2},{"itemOID":"ADTTE.AVAL","name":"AVAL","label":"Analysis Value","dataType":"integer"},{"itemOID":"ADTTE.STARTDT","name":"STARTDT","label":"Time to Event Origin Date for Subject","dataType":"date","targetDataType":"integer","displayFormat":"DATE9."},{"itemOID":"ADTTE.ADT","name":"ADT","label":"Analysis Date","dataType":"date","targetDataType":"integer","displayFormat":"DATE9."},{"itemOID":"ADTTE.CNSR","name":"CNSR","label":"Censor","dataType":"integer"},{"itemOID":"ADTTE.EVNTDESC","name":"EVNTDESC","label":"Event or Censoring Description","dataType":"string","length":25},{"itemOID":"ADTTE.SRCDOM","name":"SRCDOM","label":"Source Domain","dataType":"string","length":4},{"itemOID":"ADTTE.SRCVAR","name":"SRCVAR","label":"Source Variable","dataType":"string","length":6},{"itemOID":"ADTTE.SRCSEQ","name":"SRCSEQ","label":"Source Sequence Number","dataType":"integer"},{"itemOID":"ADTTE.SAFFL","name":"SAFFL","label":"Safety Population Flag","dataType":"string","length":1}],"rows":[["CDISCPILOT01","701","01-701-1015",63,"<65",1,"WHITE",1,"F","2014-01-02","2014-07-02",182,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",2,"2014-01-02","2014-01-03",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1023",64,"<65",1,"WHITE",1,"M","2012-08-05","2012-09-01",28,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",3,"2012-08-05","2012-08-07",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1028",71,"65-80",2,"WHITE",1,"M","2013-07-19","2014-01-14",180,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",3,"2013-07-19","2013-07-21",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1033",74,"65-80",2,"WHITE",1,"M","2014-03-18","2014-03-31",14,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",28,"2014-03-18","2014-04-14",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1034",77,"65-80",2,"WHITE",1,"F","2014-07-01","2014-12-30",183,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",58,"2014-07-01","2014-08-27",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1047",85,">80",3,"WHITE",1,"F","2013-02-12","2013-03-09",26,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",46,"2013-02-12","2013-03-29",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1097",68,"65-80",2,"WHITE",1,"M","2014-01-01","2014-07-09",190,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",3,"2014-01-01","2014-01-03",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1111",81,">80",3,"WHITE",1,"F","2012-09-07","2012-09-16",10,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",11,"2012-09-07","2012-09-17",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1115",84,">80",3,"WHITE",1,"M","2012-11-30","2013-01-23",55,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",3,"2012-11-30","2012-12-02",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1118",52,"<65",1,"WHITE",1,"M","2014-03-12","2014-09-09",182,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",182,"2014-03-12","2014-09-09",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1130",84,">80",3,"WHITE",1,"M","2014-02-15","2014-08-16",183,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",97,"2014-02-15","2014-05-22",0,"Dematologic Event Occured","ADAE","ASTDT",7,"Y"],["CDISCPILOT01","701","01-701-1133",81,">80",3,"WHITE",1,"F","2012-10-28","2013-04-28",183,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",61,"2012-10-28","2012-12-27",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1146",75,"65-80",2,"WHITE",1,"F","2013-05-20","2013-06-26",38,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",13,"2013-05-20","2013-06-01",0,"Dematologic Event Occured","ADAE","ASTDT",3,"Y"],["CDISCPILOT01","701","01-701-1148",57,"<65",1,"WHITE",1,"M","2013-08-23","2014-02-20",182,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",3,"2013-08-23","2013-08-25",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1153",79,"65-80",2,"WHITE",1,"F","2013-09-23","2014-03-16",175,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",191,"2013-09-23","2014-04-01",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1180",56,"<65",1,"WHITE",1,"M","2013-02-12","2013-03-18",35,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",36,"2013-02-12","2013-03-19",0,"Dematologic Event Occured","ADAE","ASTDT",7,"Y"],["CDISCPILOT01","701","01-701-1181",79,"65-80",2,"WHITE",1,"F","2013-12-05","2013-12-09",5,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",8,"2013-12-05","2013-12-12",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","701","01-701-1188",71,"65-80",2,"WHITE",1,"M","2013-02-15","2013-03-24",38,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",2,"2013-02-15","2013-02-16",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","701","01-701-1192",80,"65-80",2,"WHITE",1,"F","2012-07-22","2013-01-20",183,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",17,"2012-07-22","2012-08-07",0,"Dematologic Event Occured","ADAE","ASTDT",3,"Y"],["CDISCPILOT01","701","01-701-1203",81,">80",3,"BLACK OR AFRICAN AMERICAN",2,"F","2013-02-02","2013-08-03",183,"Placebo","Placebo",0,"Time to First Dermatologic 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Dose",81,"Time to First Dermatologic Event","TTDE",2,"2012-12-14","2012-12-15",0,"Dematologic Event Occured","ADAE","ASTDT",2,"Y"],["CDISCPILOT01","716","01-716-1418",80,"65-80",2,"WHITE",1,"F","2013-05-05","2013-11-20",200,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",1,"2013-05-05","2013-05-05",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","716","01-716-1441",85,">80",3,"WHITE",1,"M","2014-01-22","2014-07-22",182,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",110,"2014-01-22","2014-05-11",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","716","01-716-1447",72,"65-80",2,"WHITE",1,"F","2013-12-16","2014-06-17",184,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",30,"2013-12-16","2014-01-14",0,"Dematologic Event Occured","ADAE","ASTDT",2,"Y"],["CDISCPILOT01","717","01-717-1004",80,"65-80",2,"WHITE",1,"F","2014-01-14","2014-07-16",184,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",2,"2014-01-14","2014-01-15",0,"Dematologic Event Occured","ADAE","ASTDT",6,"Y"],["CDISCPILOT01","717","01-717-1109",84,">80",3,"WHITE",1,"M","2014-01-27","2014-07-28",183,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",20,"2014-01-27","2014-02-15",0,"Dematologic Event Occured","ADAE","ASTDT",2,"Y"],["CDISCPILOT01","717","01-717-1174",73,"65-80",2,"WHITE",1,"M","2013-01-22","2013-07-24",184,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",5,"2013-01-22","2013-01-26",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","717","01-717-1201",85,">80",3,"WHITE",1,"F","2013-12-19","2014-02-21",65,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",1,"2013-12-19","2013-12-19",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","717","01-717-1344",64,"<65",1,"WHITE",1,"F","2014-01-11","2014-03-14",63,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",63,"2014-01-11","2014-03-14",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","717","01-717-1357",77,"65-80",2,"WHITE",1,"M","2013-05-01","2013-10-14",167,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",23,"2013-05-01","2013-05-23",0,"Dematologic Event Occured","ADAE","ASTDT",2,"Y"],["CDISCPILOT01","717","01-717-1446",75,"65-80",2,"WHITE",1,"F","2013-09-01","2014-03-03",184,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",19,"2013-09-01","2013-09-19",0,"Dematologic Event Occured","ADAE","ASTDT",3,"Y"],["CDISCPILOT01","718","01-718-1066",79,"65-80",2,"WHITE",1,"F","2013-07-07","2013-07-16",10,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",24,"2013-07-07","2013-07-30",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","718","01-718-1079",67,"65-80",2,"WHITE",1,"F","2012-09-19","2012-10-31",43,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",17,"2012-09-19","2012-10-05",0,"Dematologic Event Occured","ADAE","ASTDT",2,"Y"],["CDISCPILOT01","718","01-718-1101",82,">80",3,"BLACK OR AFRICAN AMERICAN",2,"M","2013-02-17","2013-07-31",165,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",167,"2013-02-17","2013-08-02",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","718","01-718-1139",77,"65-80",2,"WHITE",1,"M","2013-05-19","2013-11-17",183,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",183,"2013-05-19","2013-11-17",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","718","01-718-1150",73,"65-80",2,"WHITE",1,"F","2013-01-19","2013-07-29",192,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",56,"2013-01-19","2013-03-15",0,"Dematologic Event Occured","ADAE","ASTDT",3,"Y"],["CDISCPILOT01","718","01-718-1170",80,"65-80",2,"WHITE",1,"F","2013-09-16","2013-10-12",27,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",49,"2013-09-16","2013-11-03",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","718","01-718-1172",74,"65-80",2,"WHITE",1,"M","2013-09-21","2013-11-29",70,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",70,"2013-09-21","2013-11-29",1,"Study Completion Date","ADSL","RFENDT",null,"Y"],["CDISCPILOT01","718","01-718-1250",82,">80",3,"WHITE",1,"F","2013-09-21","2014-01-31",133,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",100,"2013-09-21","2013-12-29",0,"Dematologic Event Occured","ADAE","ASTDT",9,"Y"],["CDISCPILOT01","718","01-718-1254",78,"65-80",2,"WHITE",1,"M","2013-07-10","2014-01-09",184,"Xanomeline Low Dose","Xanomeline Low Dose",54,"Time to First Dermatologic Event","TTDE",35,"2013-07-10","2013-08-13",0,"Dematologic Event Occured","ADAE","ASTDT",4,"Y"],["CDISCPILOT01","718","01-718-1328",86,">80",3,"WHITE",1,"M","2013-02-01","2013-04-18",77,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",51,"2013-02-01","2013-03-23",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","718","01-718-1355",79,"65-80",2,"WHITE",1,"M","2013-02-28","2013-08-29",183,"Placebo","Placebo",0,"Time to First Dermatologic Event","TTDE",9,"2013-02-28","2013-03-08",0,"Dematologic Event Occured","ADAE","ASTDT",1,"Y"],["CDISCPILOT01","718","01-718-1371",69,"65-80",2,"WHITE",1,"F","2013-04-26","2013-08-01",98,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",29,"2013-04-26","2013-05-24",0,"Dematologic Event Occured","ADAE","ASTDT",3,"Y"],["CDISCPILOT01","718","01-718-1427",74,"65-80",2,"BLACK OR AFRICAN AMERICAN",2,"F","2012-12-17","2013-02-11",57,"Xanomeline High Dose","Xanomeline High Dose",81,"Time to First Dermatologic Event","TTDE",42,"2012-12-17","2013-01-27",0,"Dematologic Event Occured","ADAE","ASTDT",9,"Y"]]}
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/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/analysis/adam/programs/adae.sas:
--------------------------------------------------------------------------------
1 | *--------------------------------------------------------------
2 | ** pch, 1/22/12 -- added amendment 1 coding vars;
3 | ** re-arranged variable ordering;
4 | *--------------------------------------------------------------;
5 | %include "..\setup.sas";
6 |
7 | proc sort data=sdtmnew.AE OUT=AE;
8 | by USUBJID AESEQ;
9 | run;
10 | data AE;
11 | set AE;
12 | by USUBJID AESEQ;
13 | ASTDT=input(strip(AESTDTC),?? yymmdd10.);
14 | AENDT=input(strip(AEENDTC),?? yymmdd10.);
15 | if ASTDT>.z and AENDT>.z then ADUR=AENDT-ASTDT+1;
16 | format ASTDT AENDT DATE9.;
17 | run;
18 |
19 | proc sort data=adamnew.ADSL OUT=TEMP(keep=SITEID USUBJID TRT01A TRT01AN AGE AGEGR1 AGEGR1N RACE RACEN SEX SAFFL
20 | TRTSDT TRTEDT RENAME=(TRT01A=TRTA TRT01AN=TRTAN));
21 | by USUBJID;
22 | run;
23 |
24 | data AE;
25 | merge AE(in=inAE) TEMP;
26 | by USUBJID;
27 | if inAE;
28 | if ASTDT=. and length(AESTDTC)=7 /*and input(strip(substr(AESTDTC,1,4)),?? best.)=year(TRTSDT)*/ then do;
29 | ASTDT=input(compress(AESTDTC||'-01'), yymmdd10.);
30 | ASTDTF='D';
31 | end;
32 | length CQ01NAM $25;
33 | IF ASTDT>=TRTSDT>.z then ASTDY=ASTDT-TRTSDT+1;
34 | ELSE IF TRTSDT>ASTDT>.z then ASTDY=ASTDT-TRTSDT;
35 | IF AENDT>=TRTSDT>.z then AENDY=AENDT-TRTSDT+1;
36 | ELSE IF TRTSDT>AENDT>.z then AENDY=AENDT-TRTSDT;
37 | IF ASTDT>.z and TRTSDT>.z then ANLSTDY=ASTDT-TRTSDT+1;
38 | *IF .z=TRTSDT>.z) then TRTEMFL='Y';
41 | ELSE TRTEMFL='N';
42 | IF index(aedecod,'APPLICATION') or
43 | index(aedecod,'DERMATITIS') or
44 | index(aedecod,'ERYTHEMA') or
45 | index(aedecod,'BLISTER') or
46 | (aebodsys='SKIN AND SUBCUTANEOUS TISSUE DISORDERS' and aedecod not in ('COLD SWEAT','HYPERHIDROSIS','ALOPECIA'))
47 | then CQ01NAM='DERMATOLOGIC EVENTS';
48 | run;
49 | /*
50 | proc freq data=AE;
51 | tables TRTEMFL*ATRTEMFL / missing list;
52 | run;
53 | */
54 | %macro flagfrst(inds=,sortvars=, invar=,outvar=,outds=, ser=, derm=);
55 |
56 | proc sort data=&inds out=ds01;
57 | by usubjid &sortvars ASTDT;
58 | where trtemfl='Y'
59 | %if &invar ne %then and &invar ne '';
60 | %if &ser ne %then and aeser='Y';
61 | %if &derm ne %then and CQ01NAM='DERMATOLOGIC EVENTS';
62 | ;
63 | run;
64 |
65 | data ds02(keep=usubjid &outvar aeseq);
66 | set ds01;
67 | by usubjid &sortvars ASTDT;
68 | if %if &invar= %then first.usubjid; %else first.&invar; then do ;
69 | &outvar='Y';
70 | output;
71 | end;
72 | run;
73 | proc sort data=ds02 out=&outds;
74 | by usubjid aeseq;
75 | run;
76 | %mend flagfrst;
77 |
78 | %* Create first ae flag;
79 |
80 | %flagfrst(inds=ae,sortvars=,invar=,outvar=AOCCFL,outds=aea);
81 | %flagfrst(inds=ae,sortvars=aebodsys,invar=aebodsys,outvar=AOCCSFL,outds=aeb);
82 | %flagfrst(inds=ae,sortvars=aebodsys aedecod,invar=aedecod,outvar=AOCCPFL,outds=aec);
83 |
84 | *%flagfrst(inds=ae,sortvars=,invar=,outvar=SAEFL,outds=saea, ser=Y);
85 | *%flagfrst(inds=ae,sortvars=aebodsys,invar=aebodsys,outvar=SBODFL,outds=saeb,ser=Y);
86 | *%flagfrst(inds=ae,sortvars=aebodsys aedecod,invar=aedecod,outvar=SDECODFL,outds=saec,ser=Y);
87 | %flagfrst(inds=ae,sortvars=,invar=,outvar=AOCC02FL,outds=saea, ser=Y);
88 | %flagfrst(inds=ae,sortvars=aebodsys,invar=aebodsys,outvar=AOCC03FL,outds=saeb,ser=Y);
89 | %flagfrst(inds=ae,sortvars=aebodsys aedecod,invar=aedecod,outvar=AOCC04FL,outds=saec,ser=Y);
90 | %flagfrst(inds=ae,sortvars=,invar=,outvar=AOCC01FL,outds=derm, ser=,derm=Y);
91 |
92 | proc sort data=AE;
93 | by usubjid aeseq;
94 | run;
95 | data AE;
96 | merge AE AEA AEB AEC SAEA SAEB SAEC DERM;
97 | by usubjid aeseq;
98 | label /*AESERN = 'Serious Event (N)'*/
99 | /*ONTRTFL = 'On or Off Study Treatment Flag'*/
100 | TRTEMFL = 'Treatment Emergent Analysis Flag'
101 | AOCCFL = '1st Occurrence of Any AE Flag'
102 | AOCCSFL = '1st Occurrence of SOC Flag'
103 | AOCCPFL = '1st Occurrence of Preferred Term Flag'
104 | /*SAEFL = '1st Serious Occurrence Flag'
105 | SBODFL = '1st Serious Ocurrence of SOC Flag'
106 | SDECODFL = '1st Serious Ocurrence of Term Flag'*/
107 | ASTDT = 'Analysis Start Date'
108 | ASTDTF = 'Analysis Start Date Imputation Flag'
109 | ASTDY = 'Analysis Start Relative Day'
110 | /*ANLSTDY = 'Analysis Start Day'*/
111 | AENDT = 'Analysis End Date'
112 | AENDY = 'Analysis End Relative Day'
113 | TRTA = 'Actual Treatment'
114 | TRTAN = 'Actual Treatment (N)'
115 | CQ01NAM='Customized Query 01 Name'
116 | AOCC02FL='1st Occurrence 02 Flag for Serious'
117 | AOCC03FL='1st Occurrence 03 Flag for Serious SOC'
118 | AOCC04FL='1st Occurrence 04 Flag for Serious PT'
119 | AOCC01FL='1st Occurrence 01 Flag for CQ01'
120 | ADUR='AE Duration (days)'
121 | ;
122 | run;
123 | data AE;
124 | retain STUDYID SITEID USUBJID TRTA TRTAN AGE AGEGR1 AGEGR1N RACE RACEN SEX SAFFL TRTSDT TRTEDT
125 | ASTDT ASTDTF ASTDY AENDT AENDY ADUR AETERM
126 | AELLT AELLTCD AEDECOD AEPTCD AEHLT AEHLTCD AEHLGT AEHLGTCD AEBODSYS AESOC AESOCCD AESEV AESER AESCAN AESCONG AESDISAB AESDTH AESHOSP AESLIFE AESOD AEREL AEACN
127 | AEOUT AESEQ TRTEMFL AOCCFL AOCCSFL AOCCPFL AOCC02FL AOCC03FL AOCC04FL CQ01NAM AOCC01FL ;
128 | set AE(keep=STUDYID SITEID USUBJID /*SUBJID*/ TRTAN TRTA AESEQ /*AESPID*/ AETERM AELLT: AEDECOD AEPTCD AEHL: AEBODSYS AESOC: AESEV AESER AEACN AEREL AEOUT AESCAN AESCONG AESDISAB
129 | AESDTH AESHOSP AESLIFE AESOD /*AEDTC AESTDTC AEENDTC AESTDY AEENDY*/ TRTEMFL /*AESERN*/ ASTDT AENDT
130 | ASTDTF CQ01NAM ASTDY AENDY /*ANLSTDY ONTRTFL*/ AOCCFL AOCCSFL AOCCPFL /*SAEFL SBODFL SDECODFL*/ AOCC01FL AOCC02FL AOCC03FL AOCC04FL
131 | AGE AGEGR1 AGEGR1N RACE RACEN SEX SAFFL TRTSDT TRTEDT ADUR);
132 | by usubjid aeseq;
133 | run;
134 | data adamnew.ADAE(label='Adverse Events Analysis Dataset');
135 | set AE;
136 | by USUBJID AESEQ;
137 | format TRTSDT TRTEDT ASTDT AENDT DATE9.;
138 | run;
139 |
140 | endsas;
141 | ods rtf file="C:\Documents and Settings\kam39347\My Documents\CDISC Pilot\SDTM\ADAE.rtf";
142 | proc contents data=AE varnum;
143 | run;
144 | ods rtf close;
145 |
146 |
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/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/analysis/adam/programs/at14-5-02.sas:
--------------------------------------------------------------------------------
1 | **********************************************************************************;
2 | * Program Name: at14-5-02.sas
3 | * Purpose: combines adverse event data with subject level analysis data
4 | calculates n (%) for body system, preferred term and
5 | number of events for both and then produces adverse
6 | event table for SERIOUS events only
7 |
8 | *****************************************************************************;
9 |
10 | libname adam "C:\Documents and Settings\kam39347\My Documents\CDISC Pilot\SDTM";
11 | data ADSL;
12 | set ADAM.ADSL;
13 | run;
14 | data ADAE;
15 | set ADAM.ADAE;
16 | run;
17 | ** GET DESCRIPTIVE STATISTICS - COUNTS FREQUENCIES AND UNIQUE COUNTS AT SUBJECT, SOC AND PT LEVELS**;
18 | PROC SQL;
19 | CREATE TABLE DENOM AS
20 | SELECT COUNT(distinct usubjid) as denom, TRT01AN as TRTAN
21 | FROM ADSL(where=(SAFFL='Y'))
22 | GROUP BY TRTAN
23 | ORDER BY TRTAN;
24 | /* COUNT UNIQUE SUBJECTS BY SOC AND PREFERRED TERM AND TREATMENT */
25 | CREATE TABLE AEPTD AS
26 | SELECT COUNT(distinct usubjid) AS count, AEBODSYS, AEDECOD, TRTAN
27 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
28 | GROUP BY TRTAN, AEBODSYS, AEDECOD
29 | ORDER BY TRTAN, AEBODSYS, AEDECOD;
30 | ** COUNT ALL EVENTS BY SOC AND PREFERRED TERM AND TREATMENT **;
31 | CREATE TABLE AEPTA AS
32 | SELECT COUNT(usubjid) AS events, AEBODSYS, AEDECOD, TRTAN
33 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
34 | GROUP BY TRTAN, AEBODSYS, AEDECOD
35 | ORDER BY TRTAN, AEBODSYS, AEDECOD;
36 | ** GET RESULTS AT PTLEVEL **;
37 | create table RESULTPT as select a.*, 3 as SUMMARYLEVEL, b.DENOM, c.events,
38 | strip(put(count,best.))||' ('||strip(put((count/denom)*100,8.1))||'%) ['||strip(put(events,best.))||']'
39 | as RESULT LENGTH=50
40 | from AEPTD as A left join DENOM as b
41 | on a.TRTAN=b.TRTAN
42 | left join AEPTA as c
43 | on a.TRTAN=c.TRTAN and a.AEBODSYS=c.AEBODSYS and a.AEDECOD=c.AEDECOD
44 | order by AEBODSYS, AEDECOD, TRTAN;
45 |
46 | /* COUNT UNIQUE SUBJECTS BY SOC AND TREATMENT */
47 | CREATE TABLE AESOCD AS
48 | SELECT COUNT(distinct usubjid) AS count, AEBODSYS, TRTAN
49 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
50 | GROUP BY TRTAN, AEBODSYS
51 | ORDER BY TRTAN, AEBODSYS;
52 | ** COUNT ALL EVENTS BY SOC TREATMENT **;
53 | CREATE TABLE AESOCA AS
54 | SELECT COUNT(usubjid) AS events, AEBODSYS, TRTAN
55 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
56 | GROUP BY TRTAN, AEBODSYS
57 | ORDER BY TRTAN, AEBODSYS;
58 | ** GET RESULTS AT SOCLEVEL **;
59 | create table RESULTSOC as select a.*, 2 as SUMMARYLEVEL, b.DENOM, c.events,
60 | strip(put(count,best.))||' ('||strip(put((count/denom)*100,8.1))||'%) ['||strip(put(events,best.))||']'
61 | as RESULT LENGTH=50
62 | from AESOCD as A left join DENOM as b
63 | on a.TRTAN=b.TRTAN
64 | left join AESOCA as c
65 | on a.TRTAN=c.TRTAN and a.AEBODSYS=c.AEBODSYS
66 | order by AEBODSYS, TRTAN;
67 |
68 | /* COUNT UNIQUE SUBJECTS BY TREATMENT */
69 | CREATE TABLE AESUBD AS
70 | SELECT COUNT(distinct usubjid) AS count, TRTAN
71 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
72 | GROUP BY TRTAN
73 | ORDER BY TRTAN;
74 | ** COUNT ALL EVENTS BY TREATMENT **;
75 | CREATE TABLE AESUBA AS
76 | SELECT COUNT(usubjid) AS events, TRTAN
77 | FROM ADAE(where=(TRTEMFL='Y' and AESER='Y'))
78 | GROUP BY TRTAN
79 | ORDER BY TRTAN;
80 | ** GET RESULTS AT SUBJECT LEVEL **;
81 | create table RESULTSUB as select a.*, 1 as SUMMARYLEVEL, b.DENOM, c.events,
82 | strip(put(count,best.))||' ('||strip(put((count/denom)*100,8.1))||'%) ['||strip(put(events,best.))||']'
83 | as RESULT LENGTH=50
84 | from AESUBD as A left join DENOM as b
85 | on a.TRTAN=b.TRTAN
86 | left join AESUBA as c
87 | on a.TRTAN=c.TRTAN
88 | order by TRTAN;
89 | QUIT;
90 | ** INFERENTIAL STATISTICS **;
91 | ** PT LEVEL **;
92 | proc sql;
93 | create table BACKBONE as select * from
94 | (select distinct USUBJID, TRT01AN as TRTAN from ADSL(where=(SAFFL='Y'))) ,
95 | (select distinct AEDECOD from ADAE(where=(TRTEMFL='Y' and AESER='Y')));
96 | create table HADEVENT as select distinct STUDYID, USUBJID, TRTAN, AEDECOD
97 | from ADAE(where=(TRTEMFL='Y' and AESER='Y'));
98 |
99 | create table FISHER as select a.USUBJID, a.TRTAN, a.AEDECOD,
100 | case when STUDYID='CDISCPILOT01' then 1
101 | else 0
102 | end as EVENT
103 | from BACKBONE a left join HADEVENT b
104 | on a.USUBJID=b.USUBJID and a.TRTAN=b.TRTAN and a.AEDECOD=b.AEDECOD
105 | order by a.AEDECOD, a.TRTAN;
106 | quit;
107 | ** HIGH DOSE VERSUS PLACEBO **;
108 | proc freq data=FISHER;
109 | by AEDECOD;
110 | where TRTAN in (0,2);
111 | table TRTAN*EVENT/exact;
112 | ods output FishersExact=F1PT(where=(Name1='XP2_FISH'));
113 | run;
114 | ** LOW DOSE VERSUS PLACEBO **;
115 | proc freq data=FISHER;
116 | by AEDECOD;
117 | where TRTAN in (0,1);
118 | table TRTAN*EVENT/exact;
119 | ods output FishersExact=F2PT(where=(Name1='XP2_FISH'));
120 | run;
121 | ** SOC LEVEL**;
122 | proc sql;
123 | create table BACKBONE1 as select * from
124 | (select distinct USUBJID, TRT01AN as TRTAN from ADSL(where=(SAFFL='Y'))) ,
125 | (select distinct AEBODSYS from ADAE(where=(TRTEMFL='Y' and AESER='Y')));
126 | create table HADEVENT1 as select distinct STUDYID, USUBJID, TRTAN, AEBODSYS
127 | from ADAE(where=(TRTEMFL='Y' and AESER='Y'));
128 |
129 | create table FISHER1 as select a.USUBJID, a.TRTAN, a.AEBODSYS,
130 | case when STUDYID='CDISCPILOT01' then 1
131 | else 0
132 | end as EVENT
133 | from BACKBONE1 a left join HADEVENT1 b
134 | on a.USUBJID=b.USUBJID and a.TRTAN=b.TRTAN and a.AEBODSYS=b.AEBODSYS
135 | order by a.AEBODSYS, a.TRTAN;
136 | quit;
137 | ** HIGH DOSE VERSUS PLACEBO **;
138 | proc freq data=FISHER1;
139 | by AEBODSYS;
140 | where TRTAN in (0,2);
141 | table TRTAN*EVENT/exact;
142 | ods output FishersExact=F1SOC(where=(Name1='XP2_FISH'));
143 | run;
144 | ** LOW DOSE VERSUS PLACEBO **;
145 | proc freq data=FISHER1;
146 | by AEBODSYS;
147 | where TRTAN in (0,1);
148 | table TRTAN*EVENT/exact;
149 | ods output FishersExact=F2SOC(where=(Name1='XP2_FISH'));
150 | run;
151 | ** SUBJECT LEVEL**;
152 | proc sql;
153 | create table BACKBONE2 as select * from
154 | (select distinct USUBJID, TRT01AN as TRTAN from ADSL(where=(SAFFL='Y')));
155 | create table HADEVENT2 as select distinct STUDYID, USUBJID, TRTAN
156 | from ADAE(where=(TRTEMFL='Y' and AESER='Y'));
157 | create table FISHER2 as select a.USUBJID, a.TRTAN,
158 | case when STUDYID='CDISCPILOT01' then 1
159 | else 0
160 | end as EVENT
161 | from BACKBONE2 a left join HADEVENT2 b
162 | on a.USUBJID=b.USUBJID and a.TRTAN=b.TRTAN
163 | order by a.TRTAN;
164 | quit;
165 | ** HIGH DOSE VERSUS PLACEBO **;
166 | proc freq data=FISHER2;
167 | where TRTAN in (0,2);
168 | table TRTAN*EVENT/exact;
169 | ods output FishersExact=F1SUB(where=(Name1='XP2_FISH'));
170 | run;
171 | ** LOW DOSE VERSUS PLACEBO **;
172 | proc freq data=FISHER2;
173 | where TRTAN in (0,1);
174 | table TRTAN*EVENT/exact;
175 | ods output FishersExact=F2SUB(where=(Name1='XP2_FISH'));
176 | run;
177 |
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/updated-pilot-submission-package/900172/m5/datasets/cdiscpilot01/tabulations/sdtm/ti.json:
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1 | {"datasetJSONCreationDateTime":"2024-12-18T15:34:17","datasetJSONVersion":"1.1.0","fileOID":"CDISCPILOT01.ti","dbLastModifiedDateTime":"2012-04-04T22:16:22","originator":"CDISC Data Exchange Standards Team","sourceSystem":{"name":"SAS on X64_10PRO","version":"9.0401M7"},"studyOID":"CDISCPILOT01","metaDataVersionOID":"CDISC.SDTMIG.3.1.2","metaDataRef":"define.xml","itemGroupOID":"TI","records":31,"name":"TI","label":"Trial Inclusion/ Exclusion Criteria","columns":[{"itemOID":"TI.STUDYID","name":"STUDYID","label":"Study Identifier","dataType":"string","length":12,"keySequence":1},{"itemOID":"TI.DOMAIN","name":"DOMAIN","label":"Domain Abbreviation","dataType":"string","length":2},{"itemOID":"TI.IETESTCD","name":"IETESTCD","label":"Incl/Excl Criterion Short Name","dataType":"string","length":16,"keySequence":2},{"itemOID":"TI.IETEST","name":"IETEST","label":"Inclusion/Exclusion Criterion","dataType":"string","length":166},{"itemOID":"TI.IECAT","name":"IECAT","label":"Inclusion/Exclusion Category","dataType":"string","length":9},{"itemOID":"TI.TIRL","name":"TIRL","label":"Inclusion/Exclusion Criterion Rule","dataType":"string","length":40}],"rows":[["CDISCPILOT01","TI","INCL01","Males and postmenopausal females at least 50 years of age.","INCLUSION",""],["CDISCPILOT01","TI","INCL02","Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines (Protocol Attachment LZZT.7).","INCLUSION",""],["CDISCPILOT01","TI","INCL03","MMSE score of 10 to 23.","INCLUSION",""],["CDISCPILOT01","TI","INCL04","Modified Hachinski Ischemic Scale score of <= 4. 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