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Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | SPDEVID | USUBJID | AESEQ | AETERM | AEMODIFY | AEDECOD | AEBODSYS | AESEV | AESER | AEACN | AEACNDEV | AEREL | AERLDEV | AEOUT | AESCONG | AESDISAB | AESDTH | AESHOSP | AESLIFE | AESMIE | AECONTRT | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY |
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1 | A123 | AE |
| A2001 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | DOSE NOT CHANGED |
| DEFINITELY NOT RELATED |
| RECOVERED/RESOLVED |
|
|
|
|
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| Y | PRODUCT EXPOSURE | 2021-01-21 | 2021-01-21 | 16 | 16 | 2 | A123 | AE | VAPE-Z01 | A2001 | 1 | SKIN REDNESS | SKIN REDNESS | Skin Redness |
| MODERATE | N | DOSE NOT CHANGED | DEVICE REPLACED | PROBABLY RELATED | RELATED | RECOVERED/RESOLVED |
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| N | PRODUCT EXPOSURE | 2021-02-16 | 2021-02-21 | 8 | 13 | 3 | A123 | AE |
| A2008 | 1 | INFLUENZA | INFLUENZA | Influenza | Infections and infestations | SEVERE | Y | TRIAL INTERVENTION DISCONTINUED |
| PROBABLY NOT RELATED |
| RECOVERING/RESOLVING |
|
|
| Y | Y |
| Y | PRODUCT EXPOSURE | 2021-06-21 | 2021-06-26 | 13 | 18 |
|
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Below is the example ADAE dataset and associated metadata/
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Dataset2 |
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| USUBJID | ASTDT | ASTDTM | AENDT | AENDTM | ASTDY | AENDY | PREFL | TRTEMFL | FUPFL | AETRTEM | AOCCFL | AOCCPFL | AOCCSFL | AESER | AEREL | RELGR1 | AESEV | AEACN | TRTA | SAFFL | TRTSDT | ABC123 | 123101 | 12OCT2005 |
| 12OCT2005 |
| -1 | -1 | Y |
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| N | DEFINITELY NOT RELATED | NOT RELATED | SEVERE | NOT APPLICABLE | Product A | Y | 13OCT2005 | ABC123 | 123101 | 13OCT2005 | 13OCT2005:13:05 | 13OCT2005 | 13OCT2005:19:00 | 1 | 1 |
| Y |
| Y | Y | Y | Y | N | Product A | RELATED | MODERATE | DOSE REDUCED | Product A | Y | 13OCT2005 | ABC123 | 123101 | 21OCT2005 |
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| 9 |
|
| Y | Y | Y |
| Y | Y | Y | PROBABLY NOT RELATED | NOT RELATED | MODERATE | DOSE REDUCED | Product A | Y | 13OCT2005 |
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Definexmltable |
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Level | Dataset |
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Purpose | Analysis |
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Name | ADAE |
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| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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ADAE |
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| One record per subject | Analysis | STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, |
| ADSL.SAS/SAP | |
Definexmltable |
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Dataset | ADAE |
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Level | Variable |
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Purpose | Analysis |
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
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| Study Identifier | text |
| Req | AE.STUDYID | USUBJID | Unique Subject Identifier | text |
| Req | AE.USUBJID | ASTDT | Analysis Start Date | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric date format | ASTDTM | Analysis Start Date/Time | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric datetime format | AENDT | Analysis End Date | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric date format | AENDTM | Analysis End Date/Time | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric datetime format | ASTDY | Analysis Start Relative Day | integer |
| Cond | ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT | AENDY | Analysis End Relative Day | integer |
| Cond | AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | PREFL | Pre-treatment Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ | TRTEMFL | Treatment Emergent Analysis Flag | text | Y | Cond | If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’ | FUPFL | Follow-up Flag | text | Y | Cond | If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
| AETRTEM | Treatment Emergent Flag | text | (NY) | Perm | SUPPAE.QVAL where QNAM=’AETRTEM’. | AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each subject. | AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject. | AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each body system for each subject. | AESER | Serious Event | text | (NY) | Req | AE.AESER | AEREL | Causality | text |
| Perm | AE.AEREL | RELGR1 | Pooled Causality Group y | text |
| Perm | set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT) | AEACN | Action Taken with Study Treatment | text | (ACN) | Perm | AE.AEACN | TRTP | Planned Treatment | text |
| Cond | ADSL.TRT01P | TRTA | Actual Treatment | text |
| Cond | ADSL.TRT01A | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL | TRTSDT | Date of First Exposure to Treatment | integer |
| Perm | ADSL.TRTSDT | TRTEDT | Date of Last Exposure to Treatment | integer |
| Perm | ADSL.TRTEDT | AETERM | Reported Term for the Adverse Event | text |
| Req | AE.AETERM | AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS | AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD | AEOUT | Outcome of Adverse Event | text |
| Perm | AE.AEOUT | AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ | AESTDTC | Start Date/Time of Adverse Event | text |
| Perm | AE.AESTDTC | AEENDTC | End Date/Time of Adverse Event | text |
| Perm | AE.AEENDTC | AESTDY | Study Day of Start of Adverse Event | text |
| Perm | AE.AESTDY | AEENDY | Study Day of End of Adverse Event | text |
| Perm | AE.AEENDY | AEENRF | End Relative to Reference Period | text |
| Perm | AE.AEENRF
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