This is an example of an ADCM dataset and is based primarily on input from the SDTM CM dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
Below is is an example of the input SDTM CM datasets used to create the ADCM. Only variables needed for illustration are shown in the examples.
Dataset wrap |
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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 |
| 62 | A123 | CM | A2008 | 1 | DIOVAN | valsartan | HYPERTENSION | ANTIHYPERTENSIVES | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER | 73 | A123 | CM | A2008 | 2 | ZOLOFT | sertraline | PANIC ATTACKS | PSYCHOANALEPTICS | 50 |
| mg | TABLET | OD | ORAL | 2010-01 |
| AFTER | 84 | A123 | CM | A2008 | 3 | ASTELIN | azelastine | INFLUENZA | NASAL PREPARATIONS |
| 2 sprays in each nostril-137 mcg | mcg | SPRAY | BID | NASAL | 2006-02-26 |
| AFTER | 95 | A123 | CM | A3009 | 1 | ASPIRIN | acetylsalicylic acid | PAIN | ANALGESICS | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER |
|
|
...
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Dataset2 |
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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 |
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ADCM |
|
|
| Analysis |
| 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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| | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
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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 |
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| CM.CMTRT | CMDECOD |
| text |
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| CM.CMDECOD | CMDOSE |
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| CM.CMDOSE | CMDOSTXT |
| text |
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| CM.CMDOSTXT | CMDOSU |
| text |
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| CM.CMDOSU | CMCLAS |
| text |
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| CM.CMCLAS | SAFFL |
| text |
|
| ADSL.SAFFL | CMSEQ |
| integer |
|
| CM.CMSEQ |
|
|