TOBA-211 - Getting issue details... STATUS TOBA-212 - Getting issue details... STATUS This example assumes a simple parallel design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
- Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
- Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
- Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.
There are no other experimental factors of interest specified in the study design. In this case, the design consists of 3 trial arms, because there are 3 distinct sequences of elements, depicted as follows:
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Please move all content other than the table outside of the macro.
TOBA-210 - Getting issue details... STATUS
| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
|---|---|---|---|---|---|---|---|---|---|
| 1 | EXP1 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
| 2 | EXP1 | TA | 1 | Control | 2 | TRT01 | Vehicle Control | Treatment | |
| 3 | EXP1 | TA | 2 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
| 4 | EXP1 | TA | 2 | 100 mg/kg | 2 | TRT02 | 100 mg/kg Drug A | Treatment | |
| 5 | EXP1 | TA | 3 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
| 6 | EXP1 | TA | 3 | 500 mg/kg | 2 | TRT03 | 500 mg/kg Drug A | Treatment |
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