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Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes | |||
| STUDYID | Study Identifier | text | CM.STUDYID | |||||
| USUBJID | Unique Subject Identifier | text | CM.USUBJID | |||||
| CMTRT | text | CM.CMTRT | ||||||
| CMDECOD | text | CM.CMDECOD | ||||||
| CMCLAS | text | CM.CMCLAS | ||||||
| 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 | CM.CMDOSE | ||||
| CMDOSTXT | text | CM.CMDOSTXT | ||||||
| CMDOSU | text | CM.CMDOSU | CMCLAS | text | CM.CMCLAS | |||
| SAFFL | text | ADSL.SAFFL | ||||||
| CMSEQ | integer | CM.CMSEQ |
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 |
|---|
Y
| CMSEQ | |||
|---|---|---|---|
| ABC123 | A123 | ASPIRIN | acetylsalicylic acid |
| ANALGESICS |
| 21JAN2021 |
| 22JAN2021 | 1 |
| 2 |
| Y | Y |
| Y | Y |
| Product A |
| Y | 100 | mg |
| MIGRAINE |
| TABLET |
| ONCE |
| ORAL | 2021-01- |
| 21 |
| 2021-01- |
| 22 | 1 | |||||||||||||||
| ABC123 | A123 | DIOVAN | valsartan | ANTIHYPERTENSIVES | 01JAN2004 | M | -6230 | Y | Y |
| Product A |
| Y |
| 20 | mg |
| HYPERTENSION |
| TABLET |
| BID | ORAL | 2004 | AFTER | 2 | |||||||||||||||||||||||||
| ABC123 | A123 | ZOLOFT | sertraline | PSYCHOANALEPTICS | 01JAN2010 | D | -4038 | Y | Y | Product A | Y | 50 | mg | PANIC ATTACKS | TABLET | QD | ORAL | 2010-01 | AFTER | 3 | |||||||||
| ABC123 | A123 | 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 |
| ABC123 |
| A123 | ASPIRIN | acetylsalicylic acid | ANALGESICS | 01JAN2004 |
| -6230 | Y | Y |
| Product A | Y |
| 100 |
| mg |
| PAIN |
| TABLET |
| PRN |
| ORAL | 2004-01-01 | AFTER | 5 |
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