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Rows 1, 2, 6, 8, 9, 12, 13, 17, 18: | Show records for protocol milestones. DSTERM and DSDECOD are populated with the same value, the name of the milestone. Note that for randomization events, EPOCH = "SCREENING", because randomization occurred before the start of treatment, during the screening epoch. | Rows 3-5: | Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "TREATMENT", "FOLLOW-UP"). | Row 7: | Shows disposition of a subject who was a screen failure. The verbatim reason the subject was a screen failure is represented in DSTERM. Because the subject did not complete the screening epoch, DSDECOD is not “COMPLETED” but another appropriate controlled term, "PROTOCOL VIOLATION". The date of discontinuation is in DSSTDTC. The protocol deviation event itself would be represented in the DV dataset. | Rows 10-11: | Show disposition of a subject who completed the screening stage but did not complete the treatment stage. For completed epochs, both DSTERM and DSDECOD are "COMPLETED". For epochs that were not completed, the verbatim reason for non-completion of the treatment epoch is in DSTERM, while the value from controlled terminology is in DSDECOD. | Rows 14-16: | Show disposition of a subject who completed treatment, but did not complete follow-up. Note that for final disposition event, the date of collection of the event information, DSDTC, was different from the date of the disposition event (the subject's death), DSSTDTC. | Rows 19-21: | Show disposition of a subject who discontinued the treatment epoch due to an adverse event, but who went on to complete the follow-up phase of the trial. |
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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 | ABC123 | DS | 123101 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-21 | 2003-09-21 | 2 | ABC123 | DS | 123101 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | 3 | ABC123 | DS | 123101 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-29 | 4 | ABC123 | DS | 123101 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-31 | 2003-10-31 | 5 | ABC123 | DS | 123101 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-15 | 2003-11-15 | 6 | ABC123 | DS | 123102 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-11-21 | 2003-11-21 | 7 | ABC123 | DS | 123102 | 2 | SUBJECT DENIED MRI PROCEDURE | PROTOCOL VIOLATION | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-11-22 | 2003-11-20 | 8 | ABC123 | DS | 123103 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-15 | 2003-09-15 | 9 | ABC123 | DS | 123103 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | 10 | ABC123 | DS | 123103 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | 11 | ABC123 | DS | 123103 | 4 | SUBJECT MOVED | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-31 | 2003-10-31 | 12 | ABC123 | DS | 123104 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-15 | 2003-09-15 | 13 | ABC123 | DS | 123104 | 3 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-30 | 2003-09-30 | 14 | ABC123 | DS | 123104 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | 15 | ABC123 | DS | 123104 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-15 | 2003-10-15 | 16 | ABC123 | DS | 123104 | 5 | AUTOMOBILE ACCIDENT | DEATH | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-10-31 | 2003-10-29 | 17 | ABC123 | DS | 123105 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
| SCREENING | 2003-09-28 | 2003-09-28 | 18 | ABC123 | DS | 123105 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
| SCREENING | 2003-10-02 | 2003-10-02 | 19 | ABC123 | DS | 123105 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-10-02 | 2003-10-02 | 20 | ABC123 | DS | 123105 | 4 | ANEMIA | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-17 | 2003-10-17 | 21 | ABC123 | DS | 123105 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-02 | 2003-11-02 |
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