This is an example of an ADAE dataset and is based primarily on input from the SDTM AE dataset. Other adminstrative administrative data about the subjects are based on the ADSL datset provided dataset provided in Section x.x, Analysis Data Subject Level (ADSL). Only variables needed for illustration are shown in the examples.
| Example |
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This is an example of the input SDTM AE datasets used to create the ADAE. | Include Page |
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| SDTM Example ADaM AE |
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| SDTM Example ADaM AE |
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Below is the example ADAE dataset and associated metadata. This is just an example and does not mean to indicate that ADAE must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. |
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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 |
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| 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 |
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| 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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