SEND Example.In vivo TX Example 1

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. There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the applicant has chosen to provide a small amount of additional information about each trial set, including the associated arm code, applicant-defined protocol group number, control group type, group label, and dose level and units, and the applicant has made the assumption that male and female animals will be compared separately when relevant.

tx.xpt

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	EXP1	TX	1	Control Group, Vehicle Control once daily	1	ARMCD	Arm Code	1
2	EXP1	TX	1	Control Group, Vehicle Control once daily	2	SPGRPCD	Applicant-Defined Group Code	1
3	EXP1	TX	1	Control Group, Vehicle Control once daily	3	TCNTRL	Control Type	Vehicle Control
4	EXP1	TX	1	Control Group, Vehicle Control once daily	4	GRPLBL	Group Label	Group 1, Control
5	EXP1	TX	1	Control Group, Vehicle Control once daily	5	TRTDOS	Dose Level	0
6	EXP1	TX	1	Control Group, Vehicle Control once daily	6	TRTDOSU	Dose Units	mg/kg/day
7	EXP1	TX	2	Low-Dose Group, 100 mg/kg Drug a once daily	7	ARMCD	Arm Code	2
8	EXP1	TX	2	Low-Dose Group, 100 mg/kg Drug a once daily	8	SPGRPCD	Applicant-Defined Group Code	2
9	EXP1	TX	2	Low-Dose Group, 100 mg/kg Drug a once daily	9	GRPLBL	Group Label	Group 2, 100 mg/kg/day
10	EXP1	TX	2	Low-Dose Group, 100 mg/kg Drug a once daily	10	TRTDOS	Dose Level	100
11	EXP1	TX	2	Low-Dose Group, 100 mg/kg Drug a once daily	11	TRTDOSU	Dose Units	mg/kg/day
12	EXP1	TX	3	High-Dose Group, 500 mg/kg Drug a once daily	12	ARMCD	Arm Code	3
13	EXP1	TX	3	High-Dose Group, 500 mg/kg Drug a once daily	13	SPGRPCD	Applicant-Defined Group Code	3
14	EXP1	TX	3	High-Dose Group, 500 mg/kg Drug a once daily	14	GRPLBL	Group Label	Group 3, 500 mg/kg/day
15	EXP1	TX	3	High-Dose Group, 500 mg/kg Drug a once daily	15	TRTDOS	Dose Level	500
16	EXP1	TX	3	High-Dose Group, 500 mg/kg Drug a once daily	16	TRTDOSU	Dose Units	mg/kg/day

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SEND Example.In vivo TX Example 1