This is an example of an ADaM dataset designed to describe the main variables needed to perform a PK Parameter summary. The dataset decribed below is called ADPP and is based on the SDTM PP dataset shown here SDTM Example.Pharmacokinetics Parameters .
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 the ones those that would be used in a particular study. One item to note is the use of PARQUAL which is not yet included in any ADaMIG but , which will appear in a future version of the ADaM.
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The ADaM ADLS associated with this study are not shown. An example on the creation of an ADLS for another study is provided here ADaM Example.ADSL Analysis Data Subject Level New |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADPP |
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| STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, | ADPP.xpt | ADPP.SAS/SAP | | 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 | Notes |
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| STUDYID | Study Identifier | text | ABC-123 | ADSL.STUDYID |
USUBJID | Unique Subject Identifier | text | PP.STUDYID | | TRTA | Actual Treatment | text | Drug A | ADSL.TRT01A |
| AVISIT | Analysis Visit | text | Day 1 | Set to propcase of PP.VISIT |
| PARQUAL | Parameter Qualifier | text | NICOTINE
COTININE
NNN | PP.PPCAT |
| PARAM | Parameter | text | AUC All (h*ng/mL)
Max Conc (ng/mL)
Time of CMAX (h) | Assigned |
| PARAMCD | Parameter Code | text | AUCALL
CMAX
TMAX | Assigned |
AVAL | Analysis Value | float | PP.PPSTRESN | | PPSPEC | Specimen Material Type | text | PLASMA | PP.PPSPEC |
PPSEQ | Sequence Number | text | PP.PPSEQ | | PKFL | PK Population Flag | text | Y;N | ADSL.PKFL |
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | USUBJID | TRTA TRTA | AVISIT | PARQUAL | PARAM | PARAMCD | AVAL AVAL | PPSPEC | PPSEQ | PKFL |
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| 1 | A123 | A2008 | Product | APP-123 | 123-0001 | Drug A | Day 1 | NICOTINE | AUC All (h*ng/mL) | AUCALL | 11.4 | PLASMA | 3 | Y | | 2 | APP-123 | 123-0001 | A123 | A2008 | Product Drug A | Day 1 | NICOTINE | Nicotine - Max Conc (ng/mL) | CMAX | 13 | PLASMA | 2 | Y | | 3 | A123 | A2008 | Product | APP-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - Time of CMAX (h) | TMAX | 5 | PLASMA | 1 | Y | | 4 | APP-123 | 123-0001 | A123 | A2008 | Product Drug A | Day 1 | COTININE | Time of CMAX (h) | TMAX | 6 | PLASMA | 5 | Y | | 5 | APP-123 | 123-0001 | A123 | A2008 | Product Drug A | Day 1 | NNN | Time of CMAX (h) | TMAX | 7 | PLASMA | 6 | Y |
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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 | |
| 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/ |
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Core | Notes |
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| STUDYID | Study Identifier | text |
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| ABC-123 | Req | ADSL.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | PP.STUDYID | | TRTA | Actual |
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| Product A | Cond | ADSL.TRT01A | | AVISIT | Analysis Visit | text | Day 1 | Cond | Set to propcase of PP.VISIT | | PARQUAL | Parameter Qualifier | text |
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NICOTINE
COTININE
NNN | Perm | PP.PPCAT | | PARAM | Parameter | text | AUC All (h*ng/mL)
Max Conc (ng/mL)
Time of CMAX (h) | Req | Assigned | | PARAMCD | Parameter Code | text | AUCALL
CMAX
TMAX | Req | Assigned |
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| AVAL | Analysis Value | float |
| Req | PP.PPSTRESN | | PPSPEC | Specimen Material Type | text | PLASMA | Perm | PP.PPSPEC | | PPSEQ |
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| Sequence Number | text |
| Perm | PP.PPSEQ | | PKFL | PK Population Flag | text | Y;N | Cond | ADSL. |
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