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This example assumes a crossover design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 10 days prior to randomization into 4 protocol groups:

  • 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 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 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 once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg 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 once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg once per day for the final 14 days.

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

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Trial Elements

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

te.xpt

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1TDM5TESCRNScreenStart of Pretreatment10 days after start of ElementP10D
2TDM5TECONTROLVehicle ControlFirst dosing with vehicle control following a nontreatment Element14 days after start of ElementP14D
3TDM5TERESTRest for 7 days1 day after last dose in a treatment Element7 days after start of ElementP7D
4TDM5TE50A50 mg/kg Drug A, once dailyFirst dosing with 50 mg/kg Drug a following a nontreatment Element14 days after start of ElementP14D
5TDM5TE400A400 mg/kg Drug A, once dailyFirst dosing with 400 mg/kg Drug a following a nontreatment Element14 days after start of ElementP14D
6TDM5TE800A800 mg/kg Drug A, once dailyFirst dosing with 800 mg/kg Drug a following a nontreatment Element14 days after start of ElementP14D
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Trial Arms


Based upon the description, there are 4 trial arms.

ta.xpt

ta.xpt

RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1TDM5TA1Control1SCRNScreenRandomized to Group 1Screen
2TDM5TA1Control2CONTROLVehicle Control
Trt 1
3TDM5TA1Control3RESTRest for 7 days
Rest 1
4TDM5TA1Control4CONTROLVehicle Control
Trt 2
5TDM5TA1Control5RESTRest for 7 days
Rest 2
6TDM5TA1Control6CONTROLVehicle Control
Trt 3
7TDM5TA250-800-4001SCRNScreenRandomized to Group 2Screen
8TDM5TA250-800-400250A50 mg/kg Drug A
Trt 1
9TDM5TA250-800-4003RESTRest for 7 days
Rest 1
10TDM5TA250-800-4004800A800 mg/kg Drug A
Trt 2
11TDM5TA250-800-4005RESTRest for 7 days
Rest 2
12TDM5TA250-800-4006400A400 mg/kg Drug A
Trt 3
13TDM5TA3400-50-8001SCRNScreenRandomized to Group 3Screen
14TDM5TA3400-50-8002400A400 mg/kg Drug A
Trt 1
15TDM5TA3400-50-8003RESTRest for 7 days
Rest 1
16TDM5TA3400-50-800450A50 mg/kg Drug A
Trt 2
17TDM5TA3400-50-8005RESTRest for 7 days
Rest 2
18TDM5TA3400-50-8006800A800 mg/kg Drug A
Trt 3
19TDM5TA4800-400-501SCRNScreenRandomized to Group 4Screen
20TDM5TA4800-400-502800A800 mg/kg Drug A
Trt 1
21TDM5TA4800-400-503RESTRest for 7 days
Rest 1
22TDM5TA4800-400-504400A400 mg/kg Drug A
Trt 2
23TDM5TA4800-400-505RESTRest for 7 days
Rest 2
24TDM5TA4800-400-50650A50 mg/kg Drug A
Trt 3
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Trial Sets


In this example, there are 4 trial sets. The experimental factors considered are type of treatment (vehicle control or compound) and sequencing of treatment levels. The sponsor is providing the arm code, sponsor-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.

tx.xpt

tx.xpt

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between1ARMCDArm Code1
2TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between2SPGRPCDSponsor-Defined Group Code1
3TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between3GRPLBLGroup LabelGroup 1, Control
4TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between4TCNTRLControl TypeVehicle Control
5TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between5TRTDOSDose Level0
6TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between6TRTDOSUDose Unitsmg/kg/day
7TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between7SPLANSUBPlanned Number of Subjects20
8TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between8ARMCDArm Code2
9TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between9SPGRPCDSponsor-Defined Group Code2
10TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between10GRPLBLGroup LabelGroup 2, 50-800-400 mg/kg/day
11TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between11TRTDOSDose LevelSEE PROTOCOL
12TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between12TRTDOSUDose UnitsSEE PROTOCOL
13TDM5TX2Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between13SPLANSUBPlanned Number of Subjects20
14TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between14ARMCDArm Code3
15TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between15SPGRPCDSponsor-Defined Group Code3
16TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between16GRPLBLGroup LabelGroup 3, 400-50-800 mg/kg/day
17TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between17TRTDOSDose LevelSEE PROTOCOL
18TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between18TRTDOSUDose UnitsSEE PROTOCOL
19TDM5TX3Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between19SPLANSUBPlanned Number of Subjects20
20TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between20ARMCDArm Code4
21TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between21SPGRPCDSponsor-Defined Group Code4
22TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between22GRPLBLGroup LabelGroup 4, 800-400-50 mg/kg/day
23TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between23TRTDOSDose LevelSEE PROTOCOL
24TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between24TRTDOSUDose UnitsSEE PROTOCOL
25TDM5TX4Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between25SPLANSUBPlanned Number of Subjects20
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