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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 | TDM5 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 |
Screen| PRE-TREATMENT | | 2 | TDM5 | TA | 1 | Control | 2 | CONTROL | Vehicle Control |
Trt 1
| TREATMENT | | 3 | TDM5 | TA | 1 | Control | 3 | REST | Rest for 7 days |
Rest 1
| WASHOUT | | 4 | TDM5 | TA | 1 | Control | 4 | CONTROL | Vehicle Control |
Trt 2
| TREATMENT | | 5 | TDM5 | TA | 1 | Control | 5 | REST | Rest for 7 days |
Rest 2
| WASHOUT | | 6 | TDM5 | TA | 1 | Control | 6 | CONTROL | Vehicle Control |
Trt 3
| TREATMENT | | 7 | TDM5 | TA | 2 | 50-800-400 | 1 | SCRN | Screen | Randomized to Group 2 |
Screen| PRE-TREATMENT | | 8 | TDM5 | TA | 2 | 50-800-400 | 2 | 50A | 50 mg/kg Drug A |
Trt 1
| TREATMENT | | 9 | TDM5 | TA | 2 | 50-800-400 | 3 | REST | Rest for 7 days |
Rest 1
| WASHOUT | | 10 | TDM5 | TA | 2 | 50-800-400 | 4 | 800A | 800 mg/kg Drug A |
Trt 2
| TREATMENT | | 11 | TDM5 | TA | 2 | 50-800-400 | 5 | REST | Rest for 7 days |
Rest 2
| WASHOUT | | 12 | TDM5 | TA | 2 | 50-800-400 | 6 | 400A | 400 mg/kg Drug A |
Trt 3
| TREATMENT | | 13 | TDM5 | TA | 3 | 400-50-800 | 1 | SCRN | Screen | Randomized to Group 3 |
Screen| PRE-TREATMENT | | 14 | TDM5 | TA | 3 | 400-50-800 | 2 | 400A | 400 mg/kg Drug A |
Trt 1
| TREATMENT | | 15 | TDM5 | TA | 3 | 400-50-800 | 3 | REST | Rest for 7 days |
Rest 1
| WASHOUT | | 16 | TDM5 | TA | 3 | 400-50-800 | 4 | 50A | 50 mg/kg Drug A |
Trt 2
| TREATMENT | | 17 | TDM5 | TA | 3 | 400-50-800 | 5 | REST | Rest for 7 days |
Rest 2
| WASHOUT | | 18 | TDM5 | TA | 3 | 400-50-800 | 6 | 800A | 800 mg/kg Drug A |
Trt 3
| TREATMENT | | 19 | TDM5 | TA | 4 | 800-400-50 | 1 | SCRN | Screen | Randomized to Group 4 |
Screen| PRE-TREATMENT | | 20 | TDM5 | TA | 4 | 800-400-50 | 2 | 800A | 800 mg/kg Drug A |
Trt 1
| TREATMENT | | 21 | TDM5 | TA | 4 | 800-400-50 | 3 | REST | Rest for 7 days |
Rest 1
| WASHOUT | | 22 | TDM5 | TA | 4 | 800-400-50 | 4 | 400A | 400 mg/kg Drug A |
Trt 2
| TREATMENT | | 23 | TDM5 | TA | 4 | 800-400-50 | 5 | REST | Rest for 7 days |
Rest 2
| WASHOUT | | 24 | TDM5 | TA | 4 | 800-400-50 | 6 | 50A | 50 mg/kg Drug A |
Trt 3 |
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Trial Sets
In this example, there are 4 trial sets. The experimental factors considered are type of treatment (vehicle control or compound) and sequencing of treatment levels. The applicant is providing the arm code, applicant-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.
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