SEND Example.In vivo TA Example 1

TOBA-211 - Getting issue details... STATUS TOBA-212 - Getting issue details... STATUS This example assumes a simple parallel design in which the applicant-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:

TOBA-210 - Getting issue details... STATUS

ta.xpt

Row	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
1	EXP1	TA	1	Control	1	SCRN	Screen	Randomized to Group 1	PRE-EXPOSURE
2	EXP1	TA	1	Control	2	TRT01	Vehicle Control		EXPOSURE
3	EXP1	TA	2	100 mg/kg	1	SCRN	Screen	Randomized to Group 2	PRE-EXPOSURE
4	EXP1	TA	2	100 mg/kg	2	TRT02	100 mg/kg Drug A		EXPOSURE
5	EXP1	TA	3	500 mg/kg	1	SCRN	Screen	Randomized to Group 3	PRE-EXPOSURE
6	EXP1	TA	3	500 mg/kg	2	TRT03	500 mg/kg Drug A		EXPOSURE

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SEND Example.In vivo TA Example 1