These are example SDTM datasets used to create the ADSL dataset. Only variables needed for illustration are shown in the examples.
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Dataset2 |
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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 | A2001 | 2001 | 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 | | M | WHITE | NOT HISPANIC OR LATINO | Plac | Placebo | Plac | Placebo |
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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 | 2021-06-21 | 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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| USA |
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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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| 2021-01-08 | 2021-01-08 | 3 | A123 | DS | A2001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-01-08 | 2021-01-08 | 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 | 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 | 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 | LOST TO FOLLOW-UP | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-06-30 | 2021-06-30 |
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