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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
|---|
| 1 | TDM1 | TA | 01 | Control | 1 | SCRN | Screen | Randomized to Group 1 | ScreenPRE-TREATMENT | | 2 | TDM1 | TA | 01 | Control | 2 | TRT01 | Vehicle Control |
| TreatmentTREATMENT | | 3 | TDM1 | TA | 01R | Control w/ Recovery | 1 | SCRN | Screen | Randomized to Group 1, planned for recovery | ScreenPRE-TREATMENT | | 4 | TDM1 | TA | 01R | Control w/ Recovery | 2 | TRT01 | Vehicle Control |
| TreatmentTREATMENT | | 5 | TDM1 | TA | 01R | Control w/ Recovery | 3 | RECO | RecoveryRecovery |
| RECOVERY | | 6 | TDM1 | TA | 02 | Low Dose | 1 | SCRN | Screen | Randomized to Group 2 | ScreenPRE-TREATMENT | | 7 | TDM1 | TA | 02 | Low Dose | 2 | TRT02 | 100 mg/kg Drug A |
| TreatmentTREATMENT | | 8 | TDM1 | TA | 02R | Low Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 2, planned for recovery | ScreenPRE-TREATMENT | | 9 | TDM1 | TA | 02R | Low Dose w/ Recovery | 2 | TRT02 | 100 mg/kg Drug A |
| TreatmentTREATMENT | | 10 | TDM1 | TA | 02R | Low Dose w/ Recovery | 3 | RECO | RecoveryRecovery |
| RECOVERY | | 11 | TDM1 | TA | 03 | High Dose | 1 | SCRN | Screen | Randomized to Group 3 | ScreenPRE-TREATMENT | | 12 | TDM1 | TA | 03 | High Dose | 2 | TRT03 | 500 mg/kg Drug A |
| TreatmentTREATMENT | | 13 | TDM1 | TA | 03R | High Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 3, planned for recovery | ScreenPRE-TREATMENT | | 14 | TDM1 | TA | 03R | High Dose w/ Recovery | 2 | TRT03 | 500 mg/kg Drug A |
| TreatmentTREATMENT | | 15 | TDM1 | TA | 03R | High Dose w/ Recovery | 3 | RECO | RecoveryRecovery |
| RECOVERY |
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Trial Sets
As noted, there are 6 distinct trial sets. The experimental factors of interest are the dose level to be received during the treatment period and whether the subjects are planned for termination on day 28 or will enter a recovery period.
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