This is an example of the ADEX metadata
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dataset and associated metadata.
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integer
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create a value for every date from EX.EXSTDTC to EX.EXENDTC
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Cumulative Actual Treatment Dose
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Safety Population Flag
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ADEX dataset
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Dataset wrap |
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Dataset2 |
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| Row | STUDYID | USUBJID | ASTDT | ASTDY | AENDT | AENDY |
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EXTRT | DOSCUMA | EXSTDTC | EXENDTC | TRTA | EXDOSE | EXDOSU | SAFFL |
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021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
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12.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
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4 | A123 | A2008 | | 1 | 14FEB2021 | 7 | e-nicotine liquid | 5 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | 5 | A123 | A2008 |
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e-nicotine liquid | 20 | 2021-02- |
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7 | A123 | A3009 | 09JUN2021 | 1 | 15JUN2021 | 7 | e-nicotine liquid |
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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 |
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ADEX | Exposure Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per product (EXTRT) per start date | Analysis | STUDYID, USUBJID, EXTRT, ASTDT | ADEX.xpt | ADEX.SAS/SAP | |
Definexmltable |
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Dataset | ADEX |
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Level | Variable |
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Purpose | Analysis |
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Name | ADEX |
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| Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes | STUDYID | Study Identifier | text |
| Req | EX.STUDYID | USUBJID | Unique Subject Identifier | text |
| Req | EX.USUBJID | ASTDT | Analysis Start Date | integer |
| Perm | EX.EXSTDTC cpatured as a numeric variable | ASTDY | Analysis Start Relative Day | integer |
| Perm | ASTDT-ADT.TRTSDT+1 | AENDT | Analysis End Date | integer |
| Perm | EX.EXENDTC cpatured as a numeric variable | AENDY | Analysis End Relative Day | integer |
| Perm | AENDT-ADT.TRTSDT+1 | EXTRT | Name of Product | text |
| Req | EX.EXTRT | DOSCUMA | Cumulative Actual Product Dose | float |
| Perm | Cumulative dose within USUBJID | EXSTDTC | Start Date/Time of Product | text |
| Perm | EX.EXSTDTC | EXENDTC | End Date/Time of Product | text |
| Perm | EX.EXENDTC | TRTA | Actual Product | text |
| Cond | ADSL.TRT01A | EXDOSE | Dose | float |
| Perm | EX.EXDOSE | EXDOSU | Dose Units | text |
| Perm | EX.EXDOSU | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL |
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Dataset wrap |
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Dataset2 |
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| Row | STUDYID | USUBJID | TRTA | PARAM | PARAMCD | PARAMN | AVAL | SAFFL |
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1 | A123 | A2001 | Placebo | Number of Days Exposed | NDAYS | 1 | | |
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2 | A123 | A2001 | Placebo | Average Daily Dose | ADD | 2 | 0.92381 | Y |
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3 | A123 | A2001 | Placebo | Total Dose | TOTDOSE | 3 | 19.4 | Y |
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4 | A123 | A2008 | Product A | Number of Days Exposed | NDAYS | 1 | 22 | Y |
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5 | A123 | A2008 | Product A | Average Daily Dose | ADD | 2 | 0.90909 | Y |
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6 | A123 | A2008 | Product A | Total Dose | TOTDOSE | 3 | 20 | Y |
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7 | A123 | A3009 | Product B | Number of Days Exposed | NDAYS | 1 | 13 | Y |
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8 | A123 | A3009 | Product B | Average Daily Dose | ADD | 2 | 1.13077 | Y |
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9 | A123 | A3009 | Product B | Total Dose | TOTDOSE | 3 | 14.7 | Y |
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Definexmltable |
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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 |
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Definexmltable |
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Dataset | ADEXSUM |
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Level | Variable |
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Purpose | Analysis |
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Name | ADEXSUM |
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Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
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| Study Identifier | Char |
| Req | ADEX.STUDYID | USUBJID | Unique Subject Identifier | Char |
| Req | ADEX.USUBJID | TRTA | Actual |
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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. |
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ADEXSUM data
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TRTA
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PARAM
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PARAMCD
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PARAMN
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AVAL
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Placebo
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Number of Doses
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NDOSES
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1
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Placebo
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Average Daily Dose
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ADD
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2
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Placebo
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Total Dose
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TOTDOSE
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3
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Product A
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Number of Doses
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NDOSES
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1
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Product A
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Average Daily Dose
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ADD
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2
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Product A
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Total Dose
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TOTDOSE
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3
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Product B
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Number of Doses
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NDOSES
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1
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Product B
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Average Daily Dose
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ADD
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2
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Product B
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Total Dose
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TOTDOSE
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3
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