This is an example of the ADEX dataset and associated metadata.
| dataset-wrap |
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| Dataset2 |
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| | Row | STUDYID | USUBJID | ASTDT | ASTDY | ADTAENDT | ADYAENDY | EXTRT | DOSCUMA | EXSTDTC | EXENDTC | TRTA | EXDOSE | EXDOSU | SAFFL |
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| 1 | A123 | A2001 | 08JAN2021 | 1 | 14JAN2021 | 7 | A2001 | 8-Jan-21 | 1 | e-nicotine liquid | | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | | 2 | e-nicotine liquid | 12 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | 10-Jan-21 | 3 | e-nicotine liquid | 18 | 021-01-08 | 2021-01-14 | Placebo | | mL | Y | A2001 | 11-Jan-21 | 4 | e-nicotine liquid | 24 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | | 2 | A123 | A2001 | 15JAN2021 | 8 | 21JAN2021 | 14 | e-nicotine liquid | 12 | 12-Jan-21 | 5 | e-nicotine liquid | 30 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | 13-Jan-21 | 6 | e-nicotine liquid | 36 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | 14-Jan-21 | 7 | e-nicotine liquid | 42 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y | A2001 | 15-Jan-21 | 8 | e-nicotine liquid | 48.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 16-Jan-21 | 9 | e-nicotine liquid | 54.8 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 17-Jan-21 | 10 | e-nicotine liquid | 61.2 | 2021-01-15 | | 3 | A123 | A2001 | 22JAN2021 | 15 | 28JAN2021 | 21 | e-nicotine liquid | 19.4 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 18-Jan-21 | 11 | e-nicotine liquid | 67.6 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 19-Jan-21 | 12 | e-nicotine liquid | 74 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 20-Jan-21 | 13 | e-nicotine liquid | 80.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 21-Jan-21 | 14 | e-nicotine liquid | 86.8 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | A2001 | 22-Jan-21 | 15 | e-nicotine liquid | 93.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 23-Jan-21 | 16 | e-nicotine liquid | 100.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 24-Jan-21 | 17 | e-nicotine liquid | 107.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 25-Jan-21 | 18 | e-nicotine liquid | 114.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 26-Jan-21 | 19 | e-nicotine liquid | 121.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 27-Jan-21 | 20 | e-nicotine liquid | 128.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | A2001 | 28-Jan-21 | 21 | e-nicotine liquid | 135.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | | 4 | A123 | A2008 | | 1 | 14FEB2021 | 7 | e-nicotine liquid | 5 | A2008 | | 1 | e-nicotine liquid | | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 9-Feb-21 | 2 | e-nicotine liquid | 10 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 10-Feb-21 | 3 | e-nicotine liquid | 15 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 11-Feb-21 | 4 | e-nicotine liquid | 20 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 12-Feb-21 | 5 | e-nicotine liquid | 25 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 13-Feb-21 | 6 | e-nicotine liquid | 30 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | A2008 | 14-Feb-21 | 7 | e-nicotine liquid | 35 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | | 5 | A123 | A2008 | 15FEB2021 | 8 | 21FEB2021 | 14 | e-nicotine liquid | 12 | A2008 | 15-Feb-21 | 8 | e-nicotine liquid | 42 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 16-Feb-21 | 9 | e-nicotine liquid | 49 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 17-Feb-21 | 10 | e-nicotine liquid | 56 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 18-Feb-21 | 11 | e-nicotine liquid | 63 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 19-Feb-21 | 12 | e-nicotine liquid | 70 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 20-Feb-21 | 13 | e-nicotine liquid | 77 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | A2008 | 21-Feb-21 | 14 | e-nicotine liquid | 84 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | | 6 | A123 | A2008 | 22FEB2021 | 15 | 01MAR2021 | 22 | e-nicotine liquid | 20 | A2008 | 22-Feb-21 | 15 | e-nicotine liquid | 92 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 23-Feb-21 | 16 | e-nicotine liquid | 100 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 24-Feb-21 | 17 | e-nicotine liquid | 108 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 25-Feb-21 | 18 | e-nicotine liquid | 116 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 26-Feb-21 | 19 | e-nicotine liquid | 124 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 27-Feb-21 | 20 | e-nicotine liquid | 132 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | | 7 | A123 | A3009 | 09JUN2021 | 1 | 15JUN2021 | 7 | A2008 | 28-Feb-21 | 21 | e-nicotine liquid | 140 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A2008 | 1-Mar-21 | 22 | e-nicotine liquid | 148 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | A3009 | 9-Jun-21 | 1 | e-nicotine liquid | 8 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | A3009 | 10-Jun-21 | 2 | e-nicotine liquid | 16 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | A3009 | 11-Jun-21 | 3 | e-nicotine liquid | 24 | 2021-06-09 | 2021-06-15 | | Product B | 8 | mLA123 | Y | A3009 | 12-Jun-21 | 4 | e-nicotine liquid | 32 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | 16JUN2021 | 8 | 21JUN2021 | 13 | A3009 | 13-Jun-21 | 5 | e-nicotine liquid | 40 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | A3009 | 14-Jun-21 | 6 | e-nicotine liquid | 48 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | A3009 | 15-Jun-21 | 7 | e-nicotine liquid | 56 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | A3009 | 16-Jun-21 | 8 | e-nicotine liquid | 62.7 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | A3009 | 17-Jun-21 | 9 | e-nicotine liquid | 69.4 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | A3009 | 18-Jun-21 | 10 | e-nicotine liquid | 76.1 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | A3009 | 19-Jun-21 | 11 | e-nicotine liquid | 82.8 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | A3009 | 20-Jun-21 | 12 | e-nicotine liquid | 89.5 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | A3009 | 21-Jun-21 | 13 | e-nicotine liquid | 96.2 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| | Definexmltable |
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| 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 |
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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 |
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 |
| 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 |
Treatment| Product | text |
| Perm | EX.EXSTDTC | | EXENDTC | End Date/Time of |
Treatment| 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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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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SAFFL
SAFFL |
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| 1 | A123 | A2001 | Placebo | Number of |
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NDAYS | 1 | | |
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| 2 | A123 | A2001 | Placebo | Average Daily Dose | ADD | 2 |
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| 92381 | Y | | 3 | A123 | A2001 | Placebo | Total Dose | TOTDOSE | 3 |
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| 4 | Y | | 4 | A123 | A2008 | Product A | Number of |
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NDAYS | 1 | 22 | Y |
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| 5 | A123 | A2008 | Product A | Average Daily Dose | ADD | 2 |
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| 90909 | Y | | 6 | A123 | A2008 | Product A | Total Dose | TOTDOSE | 3 |
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| 20 | Y | | 7 | A123 | A3009 | Product B | Number of |
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NDAYS | 1 | 13 | Y |
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| 8 | A123 | A3009 | Product B | Average Daily Dose | ADD | 2 |
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| 13077 | Y | | 9 | A123 | A3009 | Product B | Total Dose | TOTDOSE | 3 |
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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 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 |
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