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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | EPOCH | DSDTC | DSSTDTC |
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| 1 | A123 | DS | | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-01-02 | 2021-01-02 | | 2 | A123 | DS | A2001 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-01-07 | 2021-01-07 | | 3 | A123 | DS | A2001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-01-07 | 20021-01-07 | | 4 | A123 | DS | A2001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-01-28 | 2021-01-28 | | 5 | A123 | DS | A2001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-02-04 | 2021-02-04 |
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| | 6 | A123 | DS | | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-02-02 | 2021-02-02 | | 7 | A123 | DS | A2008 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-02-08 | 2021-02-08 | | 3 | A123 | DS | A2008 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-02-08 | 2021-02-08 | | 4 | A123 | DS | A2008 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-03-01 | 2021-03-01 | | 5 | A123 | DS | A2008 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-03-10 | 2021-03-10 |
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| | 8 | A123 | DS | A3009 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-06-01 | 2021-06-01 | | 9 | A123 | DS | A3009 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-06-09 | 2021-06-09 | | 10 | A123 | DS | A3009 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-06-09 | 2003-06-09 | | 10 | A123 | DS | A3009 | 4 | FLU | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-06-21 | 2021-06-21 | | 11 | A123 | DS | A3009 | 5 | COMPLETED | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-06-30 | 2021-06-30 |
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This is an example of the ADSL dataset.
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| Dataset2 |
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| STUDYID | USUBJID | SUBJID | SITEID | AGE | AGEU | AGEGR1 | SEX | RACE | ETHNIC | SAFFL | RANDFL | ARM | ACTARM | TRT01P | TRT01PN | TRT01A | TRT01AN | TRTSDT | TRTEDT | EOSSTT | EOSDT | DCSREAS |
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| A123 | A2001 | 0001 | 01 | 72 | YEARS | <65 | M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Usual Brand | Usual Brand | Product A | 1 | Usual Brand | 1 | 2021-01-08 | 2021-01-28 | COMPLETED |
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| A123 | A2008 | 2008 | 02 | 65 | YEARS |
| M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Product A | Product A | Product A | 2 | Product A | 2 | 2021-02-08 | 2021-03-01 | COMPLETED |
| ADVERSE EVENT |
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| A123 | A3009 | 3009 | 03 | 57 | YEARS |
| F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | Y | Y | Product B | Product B | Product B | 3 | Product B | 3 | 2021-06-09 | 2021-06-21 | DISCONTINUED |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADSL |
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| | Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, | ADSL.xpt | ADSL.SAS/SAP | |
| Definexmltable |
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| Dataset | ADSL |
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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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| Study Identifier | text |
| Req | AE.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | AE.USUBJID | | ASTDT | Analysis Start Date | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric date format | | ASTDTM | Analysis Start Date/Time | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric datetime format | | AENDT | Analysis End Date | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric date format | | AENDTM | Analysis End Date/Time | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric datetime format | | ASTDY | Analysis Start Relative Day | integer |
| Cond | ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT | | AENDY | Analysis End Relative Day | integer |
| Cond | AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | | PREFL | Pre-treatment Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ | | TRTEMFL | Treatment Emergent Analysis Flag | text | Y | Cond | If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’ | | FUPFL | Follow-up Flag | text | Y | Cond | If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
| | AETRTEM | Treatment Emergent Flag | text | (NY) | Perm | SUPPAE.QVAL where QNAM=’AETRTEM’. | | AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each subject. | | AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject. | | AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each body system for each subject. | | AESER | Serious Event | text | (NY) | Req | AE.AESER | | AEREL | Causality | text |
| Perm | AE.AEREL | | RELGR1 | Pooled Causality Group y | text |
| Perm | set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT) | | AEACN | Action Taken with Study Treatment | text | (ACN) | Perm | AE.AEACN | | TRTP | Planned Treatment | text |
| Cond | ADSL.TRT01P | | TRTA | Actual Treatment | text |
| Cond | ADSL.TRT01A | | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL | | TRTSDT | Date of First Exposure to Treatment | integer |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to Treatment | integer |
| Perm | ADSL.TRTEDT | | AETERM | Reported Term for the Adverse Event | text |
| Req | AE.AETERM | | AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS | | AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD | | AEOUT | Outcome of Adverse Event | text |
| Perm | AE.AEOUT | | AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ | | AESTDTC | Start Date/Time of
Adverse Event | text |
| Perm | AE.AESTDTC | | AEENDTC | End Date/Time of
Adverse Event | text |
| Perm | AE.AEENDTC | | AESTDY | Study Day of Start of
Adverse Event | text |
| Perm | AE.AESTDY | | AEENDY | Study Day of End of
Adverse Event | text |
| Perm | AE.AEENDY | | AEENRF | End Relative to
Reference Period | text |
| Perm | AE.AEENRF |
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This is an example of the ADSL dataset.
| Dataset2 |
|---|
| | STUDYID | USUBJID | SUBJID | SITEID | AGE | AGEU | AGEGR1 | SEX | RACE | ETHNIC | SAFFL | RANDFL | ARM | ACTARM | TRT01P | TRT01PN | TRT01A | TRT01AN | TRTSDT | TRTEDT | EOSSTT | EOSDT | DCSREAS |
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A123 | A2001 | 0001 | 01 | 72 | YEARS | <65 | M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Usual Brand | Usual Brand | Product A | 1 | Usual Brand | 1 | 2021-01-08 | 2021-01-28 | COMPLETED | A123 | A2008 | 2008 | 02 | 65 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Product A | Product A | Product A | 2 | Product A | 2 | 2021-02-08 | 2021-03-01 | COMPLETED | ADVERSE EVENT | A123 | A3009 | 3009 | 03 | 57 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | Y | Y | Product B | Product B | Product B | 3 | Product B | 3 | 2021-06-09 | 2021-06-21 | DISCONTINUED |
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