This is an example of an ADSL dataset and is based on input from the SDTM DM and DS domainsdatasets. This is just an example and does not mean to indicate that ADSL must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.
Below are example SDTM datasets used to create the ADSL dataset. Only variables needed for illustration are shown in the examples.
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| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | DTHDTC | DTHFL | SITEID | INVNAM | BRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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| 1 | A123 | DM | A0001 | 0001 | 2021-01-08 | 2021-01-28 | 2021-01-08 | 2021-01-28 | 2021-01-02 | 2021-02-04 |
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| 01 | JOHNSON, M | 1948-12-13 | 72 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | UB | Usual Brand | UB | Usual Brand |
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| USA | | 2 | A123 | DM | A2008 | 2008 | 2021-02-08 | 2021-03-01 | 2021-02-08 | 2021-03-01 | 2021-02-02 | 2021-03-10 |
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| 02 | JAMES,A | 1955-03-22 | 65 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | A | Product A | A | Product A |
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| USA | | 3 | A123 | DM | A3009 | 3009 | 2021-06-09 | 2006-03-19 | 2021-06-09 | 2021-06-21 | 2021-06-01 | 2021-06-30 |
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| 03 | ADAMS,J | 1964-01-19 | 57 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | B | Product B | B | Product B |
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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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