Below is an example ADaM dataset designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly inluded to support a basic summary table - for a full list of commonly used and available variables please see Section 2.3.1.1 in the OCCDS section that referecnes Concomitant Medications.
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adcm.xpt
Row
STUDYID
USUBJID
CMTRT
CMDECOD
CMCLAS
ASTDT
ASTDTF
AENDT
AENDTF
ASTDY
AENDY
AOCCFL
AOCCPFL
AOCC01FL
PREFL
ONTRTFL
FUPFL
TRTP
SAFFL
CMDOSE
CMDOSTXT
CMDOSU
CMINDC
CMDOSFRM
CMDOSFRQ
CMROUTE
CMSTDTC
CMENDTC
CMENRF
CMSEQ
1
ABC123
A2001
ASPIRIN
acetylsalicylic acid
ANALGESICS
21JAN2021
22JAN2021
1
2
Y
Y
Y
Y
Placebo
Y
100
mg
MIGRAINE
TABLET
ONCE
ORAL
2021-01-21
2021-01-22
1
2
ABC123
A2008
DIOVAN
valsartan
ANTIHYPERTENSIVES
01JAN2004
M
-6230
Y
Y
Product A
Y
20
mg
HYPERTENSION
TABLET
BID
ORAL
2004
AFTER
2
3
ABC123
A2008
ZOLOFT
sertraline
PSYCHOANALEPTICS
01JAN2010
D
-4038
Y
Y
Product A
Y
50
mg
PANIC ATTACKS
TABLET
QD
ORAL
2010-01
AFTER
3
4
ABC123
A2008
ASTELIN
azelastine
NASAL PREPARATIONS
26FEB2006
-5443
Y
Y
Product A
Y
2 sprays in each nostril-137 mcg
mcg
INFLUENZA
SPRAY
BID
NASAL
2006-02-26
AFTER
4
5
ABC123
A3009
ASPIRIN
acetylsalicylic acid
ANALGESICS
01JAN2004
-6230
Y
Y
Product B
Y
100
mg
PAIN
TABLET
PRN
ORAL
2004-01-01
AFTER
5
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ADCM Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADCM
Concomitant Medications Analysis Dataset
OCCURRENCE DATA STRUCTURE
One record per subject per medication
Analysis
STUDYID, USUBJID, CMDECOD, CMTRT
ADCM.xpt
ADCM.SAS/SAP
ADXX Variable Metadata
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
CDISC Notes
STUDYID
Study Identifier
text
Req
CM.STUDYID
USUBJID
Unique Subject Identifier
text
Req
CM.USUBJID
CMTRT
Reported Name of Drug, Med, or Therapy
text
Req
CM.CMTRT
CMDECOD
Standardized Medication Name
text
Perm
CM.CMDECOD
CMCLAS
Medication Class
text
Perm
CM.CMCLAS
ASTDT
Analysis Start Date
integer
Perm
numeric SAS date variable based on CMSTDTC with no imputation for partial dates
ASTDTF
Analysis Start Date Imputation Flag
Perm
AENDT
Analysis End Date
integer
Perm
numeric SAS date variable based on CMENDTC with no imputation for partial dates
AENDTF
Analysis End Date Imputation Flag
Perm
ASTDY
Analysis Start Relative Day
integer
Perm
ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT
AENDY
Analysis End Relative Day
integer
Perm
AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT
AOCCFL
1st Occurrence within Subject Flag
text
Y
Perm
sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record
AOCCPFL
1st Occurrence of Preferred Term Flag
text
Y
Perm
sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS and CMDECOD
AOCC01FL
1st Occurrence of CMCLAS
text
Y
Perm
sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS