Below is an example ADaM dataset designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly inluded included to support a basic summary table - for a full list of commonly used and available variables plese see Section 2.3.1.1 in the OCCDS section that referecnes Concomitant Medications.
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| Dataset2 |
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| | | 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 |
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| 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 |
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| -6230 |
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| Y | Y | Product A | Y | 20 |
| mg | HYPERTENSION | TABLET | BID | ORAL | 2004 |
| AFTER | 2 | | 3 | ABC123 | A2008 | ZOLOFT | sertraline | PSYCHOANALEPTICS | 01JAN2010 | D |
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| -4038 |
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| Y | Y | Product A | Y | 50 |
| mg | PANIC ATTACKS | TABLET | QD | ORAL | 2010-01 |
| AFTER | 3 | | 4 | ABC123 | A2008 | ASTELIN | azelastine | NASAL PREPARATIONS | 26FEB2006 |
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| -5443 |
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| 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 |
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| -6230 |
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| Y | Y | Product B | Y | 100 |
| mg | PAIN | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER | 5 |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADCM |
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| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADCM | Concomitant Medications Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per medication | Analysis | STUDYID, USUBJID, CMDECOD, CMTRT | ADCM.xpt | ADCM.SAS/SAP | |
| Definexmltable |
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| Dataset | ADCM |
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| Level | Variable |
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| Purpose | Analysis |
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| Name | ADCM |
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| 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 |
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| 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 |
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| | 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 | | PREFL | Pre- |
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product Flag
| text | Y | Cond |
| | ONTRTFL | On |
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Product
Record Flag | text | Y | Cond |
| | FUPFL | Follow-up Flag | text | Y | Cond |
| | TRTP | Planned Product | text |
| Cond | ADSL.TRT01P | | SAFFL |
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| Safety Population Flag | text |
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| Y;N | Cond | ADSL.SAFFL | | CMDOSE | Dose per Administration | integer |
| Perm | CM.CMDOSE | | CMDOSTXT | Dose Description | text |
| Perm | CM.CMDOSTXT | | CMDOSU | Dose Units | text |
| Perm | CM.CMDOSU | | CMINDC |
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| CMINDC | | CMDOSFRM | Dose Form | text |
| Perm |
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| CM.CMDOSFRM | | CMDOSFRQ | Dosing Frequency per Interval | text |
| Perm | CM. |
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Y
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| Start Date/Time of Medication | text |
| Perm | CM.CMSTDTC | | CMENDTC | End Date/Time of Medication | text |
| Perm | CM.CMENDTC | | CMENRF | End Relative to Reference Period | text |
| Perm | CM.CMENRF | | CMSEQ | Sequence Number | integer |
| Cond | CM.CMSEQ |
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