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Group 1 is a control group of 20 subjects, 10 male and 10 female, which are to be dosed with vehicle once per day for 14 days, given a 7-day rest period, dosed again with vehicle once per day for 14 days, given a second 7-day rest period, and dosed with vehicle once per day for the final 14 days.
Group 2 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 50 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 800 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 400 mg/kg of product once per day for the final 14 days.
Group 3 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 400 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg of product once per day for the final 14 days.
Group 4 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 800 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg of product once per day for the final 14 days.

There are no other experimental factors of interest specified in the study design.

Excerpt Include

	SENDIG:Figure. Example Trial 5 DesignSENDIG:
	Figure. Example Trial 5 Design

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This example shows the start and end rules and durations for the different treatment exposure elements, indicating whether they follow a treatment an exposure or nontreatment nonexposure element.

Dataset wrap

Name	te

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-216

Dataset2

Row	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
1	TDM5	TE	SCRN	Screen	Start of PretreatmentPreexposure	10 days after start of Element	P10D
2	TDM5	TE	CONTROL	Vehicle Control	First dosing with vehicle control following a nontreatment nonexposure Element	14 days after start of Element	P14D
3	TDM5	TE	REST	Rest for 7 days	1 day after last dose in a treatment an exposure Element	7 days after start of Element	P7D
4	TDM5	TE	50A	50 mg/kg Drug A, once daily	First dosing with 50 mg/kg Drug a following a nontreatment nonexposure Element	14 days after start of Element	P14D
5	TDM5	TE	400A	400 mg/kg Drug A, once daily	First dosing with 400 mg/kg Drug a following a nontreatment nonexposure Element	14 days after start of Element	P14D
6	TDM5	TE	800A	800 mg/kg Drug A, once daily	First dosing with 800 mg/kg Drug a following a nontreatment nonexposure Element	14 days after start of Element	P14D

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Dataset wrap

Name	ta

Dataset2

Row	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
1	TDM5	TA	1	Control	1	SCRN	Screen	Randomized to Group 1	PRE-TREATMENTEXPOSURE
2	TDM5	TA	1	Control	2	CONTROL	Vehicle Control		TREATMENTEXPOSURE
3	TDM5	TA	1	Control	3	REST	Rest for 7 days		WASHOUT
4	TDM5	TA	1	Control	4	CONTROL	Vehicle Control		TREATMENTEXPOSURE
5	TDM5	TA	1	Control	5	REST	Rest for 7 days		WASHOUT
6	TDM5	TA	1	Control	6	CONTROL	Vehicle Control		TREATMENTEXPOSURE
7	TDM5	TA	2	50-800-400	1	SCRN	Screen	Randomized to Group 2	PRE-TREATMENTEXPOSURE
8	TDM5	TA	2	50-800-400	2	50A	50 mg/kg Drug A		TREATMENTEXPOSURE
9	TDM5	TA	2	50-800-400	3	REST	Rest for 7 days		WASHOUT
10	TDM5	TA	2	50-800-400	4	800A	800 mg/kg Drug A		TREATMENTEXPOSURE
11	TDM5	TA	2	50-800-400	5	REST	Rest for 7 days		WASHOUT
12	TDM5	TA	2	50-800-400	6	400A	400 mg/kg Drug A		TREATMENTEXPOSURE
13	TDM5	TA	3	400-50-800	1	SCRN	Screen	Randomized to Group 3	PRE-TREATMENTEXPOSURE
14	TDM5	TA	3	400-50-800	2	400A	400 mg/kg Drug A		TREATMENTEXPOSURE
15	TDM5	TA	3	400-50-800	3	REST	Rest for 7 days		WASHOUT
16	TDM5	TA	3	400-50-800	4	50A	50 mg/kg Drug A		TREATMENTEXPOSURE
17	TDM5	TA	3	400-50-800	5	REST	Rest for 7 days		WASHOUT
18	TDM5	TA	3	400-50-800	6	800A	800 mg/kg Drug A		TREATMENTEXPOSURE
19	TDM5	TA	4	800-400-50	1	SCRN	Screen	Randomized to Group 4	PRE-TREATMENTEXPOSURE
20	TDM5	TA	4	800-400-50	2	800A	800 mg/kg Drug A		TREATMENTEXPOSURE
21	TDM5	TA	4	800-400-50	3	REST	Rest for 7 days		WASHOUT
22	TDM5	TA	4	800-400-50	4	400A	400 mg/kg Drug A		TREATMENTEXPOSURE
23	TDM5	TA	4	800-400-50	5	REST	Rest for 7 days		WASHOUT
24	TDM5	TA	4	800-400-50	6	50A	50 mg/kg Drug A		TREATMENTEXPOSURE

Trial Sets

In this example, there are 4 trial sets. The experimental factors considered are type of treatment exposure (vehicle control or compoundproduct) and sequencing of treatment exposure 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.

Dataset wrap

Name	tx

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	1	ARMCD	Arm Code	1
2	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	2	SPGRPCD	Applicant-Defined Group Code	1
3	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	3	GRPLBL	Group Label	Group 1, Control
4	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	4	TCNTRL	Control TypeVehicle Control	VEHICLE CONTROL
5	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	5	TRTDOS	Dose Level	0
6	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	6	TRTDOSU	Dose Units	mg/kg/day
7	TDM5	TX	1	Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between	7	SPLANSUB	Planned Number of Subjects	20
8	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	8	ARMCD	Arm Code	2
9	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	9	SPGRPCD	Applicant-Defined Group Code	2
10	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	10	GRPLBL	Group Label	Group 2, 50-800-400 mg/kg/day
11	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	11	TRTDOS	ITVCONC	Concentration of Intervention ArticleDose Level	SEE PROTOCOL
12	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	12	TRTDOSU	ITVCONCU	Concentration Unit for Intervention ArticleDose Units	SEE PROTOCOL
13	TDM5	TX	2	Group 2, (Compound Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between	13	SPLANSUB	Planned Number of Subjects	20
14	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	14	ARMCD	Arm Code	3
15	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	15	SPGRPCD	Applicant-Defined Group Code	3
16	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	16	GRPLBL	Group Label	Group 3, 400-50-800 mg/kg/day
17	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	17	TRTDOS	ITVCONC	Concentration of Intervention ArticleDose Level	SEE PROTOCOL
18	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	18	TRTDOSU	ITVCONCU	Concentration Unit for Intervention ArticleDose Units	SEE PROTOCOL
19	TDM5	TX	3	Group 3, (Compound Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between	19	SPLANSUB	Planned Number of Subjects	20
20	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	20	ARMCD	Arm Code	4
21	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	21	SPGRPCD	Applicant-Defined Group Code	4
22	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	22	GRPLBL	Group Label	Group 4, 800-400-50 mg/kg/day
23	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	23	TRTDOS	ITVCONC	Concentration of Intervention ArticleDose Level	SEE PROTOCOL
24	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	24	TRTDOSU	ITVCONCU	Concentration Unit for Intervention ArticleDose Units	SEE PROTOCOL
25	TDM5	TX	4	Group 4, (Compound Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between	25	SPLANSUB	Planned Number of Subjects	20

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