Date of document generation: 2014-09-07T19:49:03-04:00

Stylesheet version: 2014-09-03


ADaM Datasets for Study Derived Study built by SAS Clinical Standards Toolkit
Dataset Description Class Structure Purpose Keys Location Documentation
ADAE Adverse Event Analysis Dataset ADAE One record per subject per each AE recorded in SDTM AE domain Analysis STUDYID, USUBJID, AETERM, AESTDTC Adverse Events SAS transport file
ADQS ADaM Questionnaire Analysis Data Set BDS One record per subject per parameter per analysis visit Analysis STUDYID, USUBJID, PARAMCD, ADT ADQS SAS transport file
ADSL Subject-Level Analysis Data Set ADSL One record per subject Analysis STUDYID, USUBJID Subject-Level SAS transport file
ADTTE Time to Event Analysis Dataset BDS One record per subject per parameter per analysis visit Analysis STUDYID, USUBJID, PARAMCD, ADT ADTTE SAS transport file

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Adverse Event Analysis Dataset (ADAE) Adverse Events SAS transport file
Variable Label Type Length Display Format Code List / Controlled Terms Source/Derivation/Comments
STUDYID Study Identifier text 40
USUBJID Unique Subject Identifier text 40
AESEQ Sequence Number integer 8
AETERM Reported Term for the Adverse Event text 200
AEDECOD Dictionary-Derived Term text 200
AEBODSYS Body System or Organ Class text 80
AEBDSYCD Body System or Organ Class Code integer 8
AELLT Lowest Level Term text 100
AELLTCD Lowest Level Term Code integer 8
AEPTCD Preferred Term Code integer 8
AEHLT High Level Term text 100
AEHLTCD High Level Term Code integer 8
AEHLGT High Level Group Term text 100
AEHLGTCD High Level Group Term Code integer 8
AESOC Primary System Organ Class text 80
AESOCCD Primary System Organ Class Code integer 8
AESTDTC Start Date/Time of Adverse Event datetime ISO8601
ASTDTM Analysis Start Date/Time integer 8 DATETIME19.
ASTTMF Analysis Start Time Imputation Flag text 1 TIMEFL
AEENDTC End Date/Time of Adverse Event datetime ISO8601
AENDTM Analysis End Date/Time integer 8 DATETIME19.
AENTMF Analysis End Time Imputation Flag text 1 TIMEFL
ASTDY Analysis Start Relative Day integer 8
AENDY Analysis End Relative Day integer 8
ADURN AE Duration (N) integer 8
ADURU AE Duration Units text 40
AEDUR Duration of Adverse Event text 64
TRTEMFL Treatment Emergent Analysis Flag text 1
FUPFL Follow-up Flag text 1
AOCCFL 1st Occurrence of Any AE Flag text 1
AOCCIFL 1st Max Sev./Int. Occurrence Flag text 1
DOSEAEON Study Drug Dose at AE Onset integer 8 8.
DOSAEONU Study Drug Dose at AE Onset Units text 40
DOSECUM Cumulative Study Drug Dose float 8 6.2
DOSECUMU Cumulative Study Drug Dose Units text 40
AESER Serious Event text 2 NY
AESEV Severity/Intensity text 20 AESEV
AESEVN Severity/Intensity (N) integer 8
ASEV Analysis Severity/Intensity text 20
ASEVN Analysis Severity/Intensity (N) integer 8
SEVGR1 Pooled Severity Group y text 20
SEVGR1N Pooled Severity Group y (N) integer 8
AEREL Causality text 40
AERELN Causality (N) integer 8
AREL Analysis Causality text 40
ARELN Analysis Causality (N) integer 8
AETOXGR Standard Toxicity Grade text 20
AETOXGRN Standard Toxicity Grade (N) integer 8
AEACN Action Taken with Study Treatment text 40 ACN
SMQ01NAM SMQ zz Name text 200
SMQ01CD SMQ zz Code integer 8
SMQ01SC SMQ zz Scope text 6
SMQ01SCN SMQ zz Scope (N) integer 8
CQ01NAM Customized Query zz Name text 200
AGE Age float 8 8.1
SEX Sex text 2
TRTP Description of Planned Arm text 40
TRTEDT Date of Last Exposure to Treatment integer 8 DATE11.
TRTSDT Date of First Exposure to Treatment integer 8 DATE11.
SAFFL Safety Population Flag text 1
TRTPN Planned Treatment (N) integer 8

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ADaM Questionnaire Analysis Data Set (ADQS) ADQS SAS transport file
Variable Label Type Length Display Format Code List / Controlled Terms Source/Derivation/Comments
STUDYID Study Identifier text 40
USUBJID Unique Subject Identifier text 40
TRTP Planned Treatment text 40
TRTPN Planned Treatment (N) integer 8
ADT Analysis Date integer 8 DATE11.
ADY Analysis Relative Day integer 8
AVISIT Analysis Visit text 40
AVISITN Analysis Visit (N) integer 8 8.1
PARAM Parameter text 200
PARAMCD Parameter Code text 8
PARAMN Parameter (N) integer 8
AVAL Analysis Value integer 8 8.3
QSSEQ Sequence Number integer 8
QSCAT Category of Question text 40
QSSCAT Subcategory for Question text 40
QSORRES Finding in Original Units text 200
QSORRESU Original Units text 40
QSSTRESC Character Result/Finding in Std Format text 200
QSSTRESU Standard Units text 40
AGE Age float 8 8.1
SEX Sex text 2
TRTEDT Date of Last Exposure to Treatment integer 8 DATE11.
TRTSDT Date of First Exposure to Treatment integer 8 DATE11.
SAFFL Safety Population Flag text 1

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Subject-Level Analysis Data Set (ADSL) Subject-Level SAS transport file
Variable Label Type Length Display Format Code List / Controlled Terms Source/Derivation/Comments
STUDYID Study Identifier text 40
USUBJID Unique Subject Identifier text 40
SUBJID Subject Identifier for the Study text 40
RFSTDTC Subject Reference Start Date/Time datetime ISO8601
RFENDTC Subject Reference End Date/Time datetime ISO8601
SITEID Study Site Identifier text 40
AGE Age float 8 8.1
AGEU Age Units text 10 AGEU
SEX Sex text 2 SEX
RACE Race text 80 RACE
ARMCD Planned Arm Code text 20
ARM Description of Planned Arm text 40
VISIT1DT Date of Visit 1 integer 8 DATE11.
RANDDT Date of Randomization integer 8 DATE11.
COMPLT2 Completed 2 Weeks text 1
COMPLT4 Completed 4 Weeks text 1
COMPLT6 Completed 6 Weeks text 1
TRTEDT Date of Last Exposure to Treatment integer 8 DATE11.
TRTSDT Date of First Exposure to Treatment integer 8 DATE11.
DSDECOD Standardized Disposition Term text 200
FASFL Full Analysis Set Population Flag text 1
ITTFL Intent-To-Treat Population Flag text 1
SAFFL Safety Population Flag text 1
TRT01P Planned Treatment for Period 1 text 40
TRT01PN Planned Treatment for Period 1 (N) integer 8

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Time to Event Analysis Dataset (ADTTE) ADTTE SAS transport file
Variable Label Type Length Display Format Code List / Controlled Terms Source/Derivation/Comments
STUDYID Study Identifier text 40
USUBJID Unique Subject Identifier text 40
TRTP Planned Treatment text 40
TRTPN Planned Treatment (N) integer 8
ADT Analysis Date integer 8 DATE11.
AVISIT Analysis Visit text 40
PARAM Parameter text 200
PARAMCD Parameter Code text 8
AVAL Analysis Value integer 8 3.
STARTDT Time to Event Origin Date for Subject integer 8 DATE11.
CNSR Censor integer 8
EVNTDESC Event or Censoring Description text 200
SRCDOM Source Domain text 2
SRCVAR Source Variable text 8
SRCSEQ Source Sequence Number integer 8

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Parameter Value List - ADQS [AVAL]
Source Variable Where PARAMCD= Where PARAM= Type Length Display Format Code List / Controlled Term Source/Derivation/Comments
AVAL ACITM01 Word Recall Task integer 8 See Method: CM.ADQS.AVAL.ACITM01:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM02 Naming Objects and Fingers integer 8 See Method: CM.ADQS.AVAL.ACITM02:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM03 Delayed Word Recall integer 8 See Method: CM.ADQS.AVAL.ACITM03:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM04 Commands integer 8 See Method: CM.ADQS.AVAL.ACITM04:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM05 Constructional Praxis integer 8 See Method: CM.ADQS.AVAL.ACITM05:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM06 Ideational Praxis integer 8 See Method: CM.ADQS.AVAL.ACITM06:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM07 Orientation integer 8 See Method: CM.ADQS.AVAL.ACITM07:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM08 Word Recognition integer 8 See Method: CM.ADQS.AVAL.ACITM08:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM09 Attention/Visual Search Task integer 8 See Method: CM.ADQS.AVAL.ACITM09:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM10 Maze Solution integer 8 See Method: CM.ADQS.AVAL.ACITM10:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM11 Spoken Language Ability integer 8 See Method: CM.ADQS.AVAL.ACITM11:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM12 Comprehension of Spoken Language integer 8 See Method: CM.ADQS.AVAL.ACITM12:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM13 Word Finding Difficulty in Spontaneous Speech integer 8 See Method: CM.ADQS.AVAL.ACITM13:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACITM14 Recall of Test Instructions integer 8 See Method: CM.ADQS.AVAL.ACITM14:
QS.QSSTRESN where QSTESTCD=PARAMCD
AVAL ACTOT ADAS-COG(11) Subscore integer 8 See Method: CM.ADQS.AVAL.ACTOT:
ACTOT = Sum of ADAS scores for items 1,2,4,5,6,7,8,11,12,13,and 14
AVAL CIBIC Extent Of Change, if Any, Since Baseline Cibic integer 8

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Code List - ACN, Reference Name (CL.ACN)
Coded Value Decode
DOSE INCREASED Dose Increased
DOSE NOT CHANGED Dose Not Changed
DOSE REDUCED Dose Reduced
DRUG INTERRUPTED Drug Interrupted
DRUG WITHDRAWN Drug Withdrawn
NOT APPLICABLE Not Applicable
UNKNOWN Unknown

Code List - AESEV, Reference Name (CL.AESEV)
Coded Value Decode
MILD Mild Adverse Event
MODERATE Moderate Adverse Event
SEVERE Severe Adverse Event

Code List - AGEU, Reference Name (CL.AGEU)
Coded Value Decode
DAYS Day
HOURS Hour
MONTHS Month
WEEKS Week
YEARS Year

Code List - NY, Reference Name (CL.NY)
Coded Value Decode
N No
NA Not Applicable
U Unknown
Y Yes

Code List - RACE, Reference Name (CL.RACE)
Coded Value Decode
AMERICAN INDIAN OR ALASKA NATIVE American Indian or Alaska Native
ASIAN Asian
BLACK OR AFRICAN AMERICAN African American
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER Native Hawaiian or Other Pacific Islander
WHITE White

Code List - SEX, Reference Name (CL.SEX)
Coded Value Decode
F Female
M Male
U Unknown
UN Intersex

Code List - TIMEFL, Reference Name (CL.TIMEFL)
Coded Value Decode
H Hours Minutes Seconds Imputed
M Minutes Seconds Imputed
S Seconds Imputed

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Analysis Derivations
Method Description
CM.ADQS.AVAL.ACITM01 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM02 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM03 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM04 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM05 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM06 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM07 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM08 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM09 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM10 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM11 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM12 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM13 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACITM14 QS.QSSTRESN where QSTESTCD=PARAMCD
CM.ADQS.AVAL.ACTOT ACTOT = Sum of ADAS scores for items 1,2,4,5,6,7,8,11,12,13,and 14

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