Values from ADSL and PP are combined to capture observations that can be summarized. This is just an example and does not mean to indicate that ADPP must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study. One item to note is the use of PARQUAL, which will appear in a future version of the ADaM.
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Variable
Name
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Variable Label
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Codelist/
Controlled
Terms
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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | USUBJID | TRTA | AVISIT | PARQUAL | PARAM | PARAMCD | AVAL | PPSPEC | PPSEQ | PKFL |
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| 1 | A123 | A2008 | Product A | Day 1 | NICOTINE |
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| AUCALL | 11.4 | PLASMA | 3 | Y | | 2 | A123 | A2008 | Product A | Day 1 | NICOTINE | Max Conc (ng/mL) |
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| CMAX | 13 | PLASMA | 2 | Y | | 3 | A123 | A2008 | Product A | Day 1 | NICOTINE | Time of CMAX (h) |
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| TMAX | 5 | PLASMA | 1 | Y | | 4 | A123 | A2008 | Product A | Day 1 | COTININE | Time of CMAX (h) | TMAX | 6 | PLASMA | 5 | Y | | 5 | A123 | A2008 | Product A | Day 1 | NNN |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADPP |
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| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADPP | PP Analysis Data | Basic Data Structure | One record per subject per parameter per analysis visit | Analysis | STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, | ADPP.xpt | ADPP.SAS/SAP | |
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| Definexmltable |
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| Dataset | ADPP |
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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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| STUDYID | Study Identifier | text | ABC-123 | Req | ADSL.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | PP.STUDYID | | TRTA | Actual Product | text | Product A | Cond | ADSL.TRT01A | | AVISIT | Analysis Visit | text | Day 1 | Cond | Set to propcase of PP.VISIT | | PARQUAL | Parameter Qualifier | text | NICOTINE
COTININE
NNN | Perm | PP.PPCAT | | PARAM | Parameter | text |
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| Time of CMAX (h) | Req | Assigned | | PARAMCD | Parameter Code | text | AUCALL
CMAX
TMAX | Req | Assigned | | AVAL | Analysis Value | float |
| Req | PP.PPSTRESN | | PPSPEC | Specimen Material Type | text | PLASMA | Perm | PP.PPSPEC | | PPSEQ | Sequence Number | text |
| Perm | PP.PPSEQ | | PKFL | PK Population Flag | text | Y;N | Cond | ADSL.PKFL |
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