SEND Example.In vivo TE Example 2

This example includes the nonfixed duration for pretest phase where the end rule is not a definite time, but when the subject achieves a specified body weight. In order to completely understand the experimental design of a trial, the TA and TS datasets are needed (see Section 7.3, Trial Arms, and Section 7.4, Trial Sets).

te.xpt

Row	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
1	EXP7	TE	PRETEST	Pretreatment Feeding Period	Start of pretreatment period	When subject's body weight is at least 750 g
2	EXP7	TE	CONTROL	Control Period	After completion of PRETEST Element	30 days after start of Element	P30D
3	EXP7	TE	TREAT2	100 mg/kg Drug A, once daily	After completion of PRETEST Element	30 days after start of Element	P30D
4	EXP7	TE	TREAT3	200 mg/kg Drug A, once daily	After completion of PRETEST Element	30 days after start of Element	P30D
5	EXP7	TE	TREAT4	300 mg/kg Drug A, once daily	After completion of PRETEST Element	30 days after start of Element	P30D
6	EXP7	TE	TREAT5	100 mg/kg Drug B, twice daily doses of 50 mg/kg each	After completion of PRETEST Element	30 days after start of Element	P30D
7	EXP7	TE	TREAT6	200 mg/kg Drug B, twice daily doses of 100 mg/kg each	After completion of PRETEST Element	30 days after start of Element	P30D
8	EXP7	TE	TREAT7	400 mg/kg Drug B, twice daily doses of 200 mg/kg each	After completion of PRETEST Element	30 days after start of Element	P30D
9	EXP7	TE	RECOVERY	Recovery Period	After last dose with treatment or vehicle control	14 days after start of Element	P14D

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SEND Example.In vivo TE Example 2