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High Dose Changed from 900 mg/kg to 700 mg/kg |
In this example, the high-dose group originally scheduled to get 900 mg/kg was intentionally changed to 700 mg/kg after 1 week of the study. Prior to this change, a protocol amendment was created that altered the plan; therefore, this element would appear in TA, Trial Elements (TE), and SE.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
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| 1 | CDF2 | SE | CDF2-001 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | | 2 | CDF2 | SE | CDF2-001 | 2 | TREATA | Control | 2008-01-14T07:00 | 2008-01-27T09:00 | | 3 | CDF2 | SE | CDF2-001 | 3 | RECOVERY | Rest | 2008-01-27T09:00 | 2008-02-02T07:00 | | 4 | CDF2 | SE | CDF2-010 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | | 5 | CDF2 | SE | CDF2-010 | 2 | TREATB | 100 mg/kg Product A | 2008-01-14T07:00 | 2008-01-27T09:30 | | 6 | CDF2 | SE | CDF2-010 | 3 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 | | 7 | CDF2 | SE | CDF2-020 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | | 8 | CDF2 | SE | CDF2-020 | 2 | TREATC | 300 mg/kg Product A | 2008-01-14T07:00 | 2008-01-27T10:30 | | 9 | CDF2 | SE | CDF2-020 | 3 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 | | 10 | CDF2 | SE | CDF2-030 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | | 11 | CDF2 | SE | CDF2-030 | 2 | TREATD | 900 mg/kg Product A | 2008-01-14T07:00 | 2008-01-21T07:00 | | 12 | CDF2 | SE | CDF2-030 | 3 | TREATD2 | 700 mg/kg Product A | 2008-01-21T07:00 | 2008-01-27T09:30 | | 13 | CDF2 | SE | CDF2-030 | 4 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 | | 14 | CDF2 | SE | CDF2-040 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | | 15 | CDF2 | SE | CDF2-040 | 2 | TREATE | Positive Control Product XY | 2008-01-14T07:00 | 2008-01-27T10:30 |
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