This is an example of the ADEX 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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ADEX dataset
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1
| AENDT | AENDY | EXTRT | DOSCUMA | EXSTDTC | EXENDTC | TRTA | EXDOSE | EXDOSU | SAFFL |
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| 1 | A123 | A2001 | 08JAN2021 | 1 | 14JAN2021 | 7 | e-nicotine liquid |
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15JAN2021 | 8 | 21JAN2021 | 14 | e-nicotine liquid |
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| 22JAN2021 | 15 | 28JAN2021 | 21 | e-nicotine liquid | 19.4 | 2021 |
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| A2008 | | 1 | 14FEB2021 | 7 | e-nicotine liquid |
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| A2008 | 15FEB2021 | 8 | 21FEB2021 | 14 | e-nicotine liquid |
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| 01MAR2021 | 22 | e-nicotine liquid | 20 | 2021-02-22 | 2021-03-01 | Product A | 8 |
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| A3009 | 09JUN2021 | 1 | 15JUN2021 | 7 | e-nicotine liquid |
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| A3009 | 16JUN2021 | 8 | 21JUN2021 | 13 | e-nicotine liquid |
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| ADEX | | 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 |
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| 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 |
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| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
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ADEXSUM data
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TRTP
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TRT01P
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TRTA
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TRT01A
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PARAM
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PARAMCD
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PARAMN
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AVAL
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Number of Doses
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NDOSES
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1
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Average Daily Dose
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ADD
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2
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Total Dose
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TOTDOSE
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3
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Number of Doses
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NDOSES
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1
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Average Daily Dose
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ADD
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2
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Total Dose
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TOTDOSE
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3
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Number of Doses
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NDOSES
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1
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Average Daily Dose
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ADD
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2
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Total Dose
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TOTDOSE
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3
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