| Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-299 |
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This is an example of the ADEX dataset and associated metadata.
...
| Definexmltable |
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| Dataset | ADEX |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADEX |
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|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
| ADEX | Exposure Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per treatment product (EXTRT) per start date | Analysis | STUDYID, USUBJID, EXTRT, ASTDT | ADEX.xpt | ADEX.SAS/SAP | |
...
| Definexmltable |
|---|
| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADEXSUM |
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|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADEXSUM | Exposure Summary Analysis Dataset | BASIC DATA STRUCTURE | One or more records per subject per analysis parameter | Analysis | STUDYID, USUBJID, PARAM | ADEXSUM.xpt | ADEXSUM.SAS/SAP |
|
| Definexmltable |
|---|
| Dataset | ADEXSUM |
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| Level | Variable |
|---|
| Purpose | Analysis |
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| Name | ADEXSUM |
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|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|
| Study Identifier | Char |
| Req | ADEX.STUDYID | | USUBJID | Unique Subject Identifier | Char |
| Req | ADEX.USUBJID | | TRTA | Actual Product | Char |
| Cond | ADEX.TRT01A | | PARAM | Parameter | Char |
| Req | Assigned | | PARAMCD | Parameter Code | text |
| Req | Assigned | | PARAMN | Parameter (N) | Num |
| Perm | Assigned | | AVAL | Analysis Value | Num |
| Cond | see parameter level metadata | | SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
|