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Definexmltable
LevelDataset
PurposeAnalysis
NameADCM
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADCMConcomitant Medications Analysis DatasetOCCURRENCE DATA STRUCTUREOne record per subject per medicationAnalysisSTUDYID, USUBJID, CMDECOD, CMTRTADCM.xptADCM.SAS/SAP
Definexmltable
DatasetADCM
LevelVariable
PurposeAnalysis
NameADCM

Variable Name

Variable LabelTypeCodelist/Controlled TermsCoreCDISC Notes
STUDYIDStudy Identifiertext
ReqCM.STUDYID
USUBJIDUnique Subject Identifiertext
ReqCM.USUBJID
CMTRTReported Name of Drug, Med, or Therapytext
ReqCM.CMTRT
CMDECODStandardized Medication Nametext
PermCM.CMDECOD
CMCLASMedication Classtext
PermCM.CMCLAS
ASTDTAnalysis Start Date

integer


Perm

numeric SAS date variable based on CMSTDTC with no imputation for partial dates

ASTDTFAnalysis Start Date Imputation Flag

Perm
AENDTAnalysis End Dateinteger
Permnumeric SAS date variable based on CMENDTC with no imputation for partial dates
AENDTFAnalysis End Date Imputation Flag

Perm
ASTDYAnalysis Start Relative Dayinteger
PermASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT
AENDYAnalysis End Relative Dayinteger
PermAENDT-TRTSDT - add one if ASTDT is on or after TRTSDT
AOCCFL1st Occurrence within Subject FlagtextYPerm

sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record

AOCCPFL1st Occurrence of Preferred Term FlagtextYPermsort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS and CMDECOD
AOCC01FL1st Occurrence of CMCLAStextYPermsort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS
PREFL

Pre-product Flag


textYCond
ONTRTFLOn Product
Record Flag		textYCond
FUPFLFollow-up FlagtextYCond
TRTPPlanned Producttext
CondADSL.TRT01P
SAFFLSafety Population FlagtextY;NCondADSL.SAFFL
CMDOSEDose per Administrationinteger
PermCM.CMDOSE
CMDOSTXTDose Descriptiontext
PermCM.CMDOSTXT
CMDOSUDose Unitstext
PermCM.CMDOSU
CMINDCIndicationtext
PermCM.CMINDC
CMDOSFRMDose Formtext
PermCM.CMDOSFRM
CMDOSFRQDosing Frequency per Intervaltext
PermCM.CMDOSFRQ
CMROUTERoute of Administrationtext
PermCM.CMROUTE
CMSTDTCStart Date/Time of Medicationtext
PermCM.CMSTDTC
CMENDTCEnd Date/Time of Medication text
PermCM.CMENDTC
CMENRFEnd Relative to Reference Periodtext
PermCM.CMENRF
CMSEQSequence Numberinteger
CondCM.CMSEQ