| Dataset wrap |
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| Dataset2 |
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| | | USUBJID | AETERM | AEMODIFY | AEDECOD | AEBODSYS | ASTDT | AENDT | ASTDY | AENDY | PREFL | TRTEMFL | FUPFL | AETRTEM | AOCCFL | AOCCPFL | AOCCSFL | AESER | AEREL | AERLDEV | RELGR1 | AESEV | AEACN | AEACNDEV | AEOUT | TRTA | SAFFL | TRTSDT | TRTEDT | AESEQ | AESTDTC | AEENDTC | AESTDY | AEENDY | AEENRF |
|---|
| 1 | A123 | A2001 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | 21JAN2021 | 21JAN2021 | 14 | 14 |
| Y |
|
|
|
|
| N | DEFINITELY NOT RELATED |
| NOT RELATED | SEVERE | DOSE NOT CHANGED |
| RECOVERED/RESOLVED | Placebo | Y | 08JAN2021 | 28JAN2021 | 1 | 2021-01-21 | 2021-01-21 | 14 | 14 |
| | 2 | A123 | A2008 | SKIN REDNESS | SKIN REDNESS | Skin Redness |
| 16FEB2021 | 21FEB2021 | 9 | 14 |
| Y |
| Y | Y | Y | Y | N | PROBABLY RELATED | RELATED | RELATED | MODERATE | DOSE NOT CHANGED | DEVICE REPLACED | RECOVERED/RESOLVED | Placebo | Y | 08FEB2021 | 01MAR2021 | 2 | 2021-02-16 | 2021-02-21 | 9 | 14 |
| | 3 | A123 | A3009 | INFLUENZA | INFLUENZA | Influenza | Infections and infestations | 21JUN2021 | 26JUN2021 | 13 | 18 |
| Y | Y | Y |
| Y | Y | Y | PROBABLY NOT RELATED |
| NOT RELATED | SEVERE | TRIAL INTERVENTION DISCONTINUED |
| RECOVERING/RESOLVING | Placebo | Y | 09JUN2021 | 21JUN2021 | 3 | 2021-06-21 | 2021-06-26 | 13 | 18 |
|
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| Definexmltable |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
| Name | ADAE |
|---|
|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per adverse event | Analysis | STUDYID, USUBJID, AEBODSYS, AEDECOD, AETERM | ADAE.xpt | ADAE.SAS/SAP | |
| Definexmltable |
|---|
| Dataset | ADAE |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| OID | ADAE |
|---|
| Name | ADAE |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier |
|
...
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...
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| | USUBJID | Unique Subject Identifier |
|
...
...
Created from converting AE.AESTDTC from character ISO8601 format to numeric date format, applying imputation rules as specified in the SAP or metadata.
Conditional on whether start date is pertinent for study and is populated in SDTM.
...
| AE.USUBJID | | AETERM | Reported Term for the Adverse Experience | text |
| Req | AE.AETERM | | AEMODIFY | Modified Reported Term | text |
| Perm | AE.MODIFY | | AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS | | AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD | | ASTDT | Analysis Start Date | integer |
|
...
|
| Cond | Created from converting |
|
...
...
AESTDTC from character ISO8601 format to numeric date format |
|
...
...
...
...
| integer |
| Cond | Created from converting |
|
...
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AEENDTC from character ISO8601 format to numeric |
|
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date format | | ASTDY | Analysis Start Relative Day |
|
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| ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT |
|
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| | AENDY | Analysis End Relative Day |
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| AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
|
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| PREFL | Pre-product Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ | | TRTEMFL | Product | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-787 |
|---|
|
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 | Product Emergent Flag | text | (NY) | Perm |
|
...
| SUPPAE.QVAL where QNAM=’AETRTEM’ |
|
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| . | | AOCCFL | 1st Occurrence within Subject Flag |
|
...
...
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| Sort the data in the required order and flag the first |
|
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| product emergent record for each subject. | | AOCCPFL | 1st Occurrence of Preferred Term Flag |
|
...
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| Sort the data in the required order and flag the first |
|
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| product emergent record for each AEDECOD for each subject. | | AOCCSFL | 1st Occurrence of SOC Flag |
|
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| Sort the data in the required order and flag the first |
|
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| product emergent record for each body system for each subject. | | AESER | |
|
...
Experience | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-788 |
|---|
|
| text | (NY) | Req | AE.AESER | | AEREL | Causality |
|
...
...
| AERLDEV | Relationship of Event to Device | text | * | Perm | AE.AERLDEV | | RELGR1 |
|
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...
...
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| 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 |
|
...
...
...
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| AEACNDEV | Action Taken with Device | text |
| Perm | AE.AEACNDEV |
|---|
| AEOUT | Outcome of Adverse Experience | text | (OUT) | Perm | AE.AEOUT |
|---|
| TRTA | Actual Product | text |
| Cond | ADSL.TRT01A | | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL | | TRTSDT | Date of First Exposure to Product | integer |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to Product | integer |
| Perm | ADSL.TRTEDT | | AEOUT | Outcome of Adverse experience | text |
| Perm | AE.AEOUT | | AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ | | AESTDTC | Start Date/Time of
Adverse Experience | text |
| Perm | AE.AESTDTC | | AEENDTC | End Date/Time of
Adverse Experience | text |
| Perm | AE.AEENDTC | | AESTDY | Study Day of Start of
Adverse Experience | text |
| Perm | AE.AESTDY | | AEENDY | Study Day of End of
Adverse Experience | text |
| Perm | AE.AEENDY | | AEENRF | End Relative to
Reference Period | text |
| Perm | AE.AEENRF |
|
...