This is an example of an ADCM dataset and is based primarily on input from the SDTM CM dataset. Below is an xxample of the SDTM CM dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMDECOD | CMINDC | CMCLAS | CMDOSE | CMDOSTXT | CMDOSU | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF |
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| 1 | A123 | CM | A2001 | 1 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL | 2021-01-21 | 2021-01-22 |
| | 6 | A123 | CM | A2008 | 1 | DIOVAN | valsartan | HYPERTENSION | ANTIHYPERTENSIVES | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER | | 7 | A123 | CM | A2008 | 2 | ZOLOFT | sertraline | PANIC ATTACKS | PSYCHOANALEPTICS | 50 |
| mg | TABLET | OD | ORAL | 2010-01 |
| AFTER | | 8 | A123 | CM | A2008 | 3 | ASTELIN | azelastine | INFLUENZA | NASAL PREPARATIONS |
| 2 sprays in each nostril-137 mcg | mcg | SPRAY | BID | NASAL | 2006-02-26 |
| AFTER | | 9 | A123 | CM | A3009 | 1 | ASPIRIN | acetylsalicylic acid | PAIN | ANALGESICS | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER |
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Below is an example ADaM CM dataset amd associate metadata 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 references Concomitant Medications.
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| USUBJID | ASTDT | AENDT | ASTDY | AENDY | CMSTDTC | CMENDTC | AOCCFL | AOCCPFL | AOCC01FL | PREFL | ONTRTFL | FUPFL | TRTP | SAFFL | CMTRT | CMDECOD | CMDOSE | CMDOSTXT | CMDOSU | CMCLAS | CMSEQ |
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| ABC123 | ABC12301001 | 01JAN2004 | 01JAN2004 | 1 | 1 | 2004-01-01 | 2004-01-01 | Y | Y | Y |
| Y |
| Product A | Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 1 | | ABC123 | ABC12301001 | 02JAN2004 | 02JAN2004 | 2 | 2 | 2004-01-02 | 2004-01-02 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 2 | | ABC123 | ABC12301001 | 03JAN2004 | 03JAN2004 | 3 | 3 | 2004-01-03 | 2004-01-03 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 3 | | ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 4 | | ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 5 | | ABC123 | ABC12301001 | 09JAN2004 | 09JAN2004 | 9 | 9 | 2004-01-09 | 2004-01-09 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 6 | | ABC123 | ABC12301002 |
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| 2004 |
| Y | Y | Y | Y | Y | Y |
| Y | DIOVAN | valsartan | 20 |
| mg | ANTIHYPERTENSIVES | 1 | | ABC123 | ABC12301002 |
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| 2004-01 |
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| Y | Y | Y | Y | Y |
| Y | ZOLOFT | sertraline | 50 |
| mg | PSYCHOANALEPTICS | 2 | | ABC123 | ABC12301002 | 09JAN2004 | 10JUN2004 | 9 | 10 | 2004-01-09 | 2004-06-10 |
| Y | Y |
| Y | Y |
| Y | ASTELIN | azelastine |
| 2 sprays in each nostril-137 mcg | mcg | NASAL PREPARATIONS | 3 | | ABC123 | ABC12301003 | 01JAN2004 |
| 1 |
| 2004-01-01 |
| Y | Y | Y | Y | Y | Y |
| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 1 |
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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 |
|---|
| ADCM |
|
|
| Analysis |
| ADCM.xpt | ADCM.SAS/SAP | |
| Definexmltable |
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| Dataset | ADCM |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|
| STUDYID | Study Identifier | text |
|
| CM.STUDYID | | USUBJID | Unique Subject Identifier | text |
|
| CM.USUBJID | | ASTDT | Analysis Start Date | integer |
|
| numeric SAS date variable based on CMSTDTC with no imputation for partial dates | | AENDT | Analysis End Date | integer |
|
| numeric SAS date variable based on CMENDTC with no imputation for partial dates | | ASTDY | Analysis Start Relative Day | integer |
|
| ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | | AENDY | Analysis End Relative Day | integer |
|
| AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | | CMSTDTC |
| text |
|
| CM.CMSTDTC | | CMENDTC |
| text |
|
| CM.CMENDTC | | 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-treatment Flag
| text | Y | Cond |
| | ONTRTFL | On Treatment
Record Flag | text | Y | Cond |
| | FUPFL | Follow-up Flag | text | Y | Cond |
| | TRTP |
| text |
|
| ADSL.TRT01P | | CMTRT |
| text |
|
| CM.CMTRT | | CMDECOD |
| text |
|
| CM.CMDECOD | | CMDOSE |
|
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| CM.CMDOSE | | CMDOSTXT |
| text |
|
| CM.CMDOSTXT | | CMDOSU |
| text |
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| CM.CMDOSU | | CMCLAS |
| text |
|
| CM.CMCLAS | | SAFFL |
| text |
|
| ADSL.SAFFL | | CMSEQ |
| integer |
|
| CM.CMSEQ |
|
|