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Comment: TOBA-544

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

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Namete

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-216

Dataset2
RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1TDM5TESCRNScreenStart of Preexposure10 days after start of ElementP10D
2TDM5TECONTROLVehicle ControlFirst dosing with vehicle control following a nonexposure Element14 days after start of ElementP14D
3TDM5TERESTRest for 7 days1 day after last dose in a product an exposure Element7 days after start of ElementP7D
4TDM5TE50A50 mg/kg Drug A, once dailyFirst dosing with 50 mg/kg Drug a following a nonexposure Element14 days after start of ElementP14D
5TDM5TE400A400 mg/kg Drug A, once dailyFirst dosing with 400 mg/kg Drug a following a nonexposure Element14 days after start of ElementP14D
6TDM5TE800A800 mg/kg Drug A, once dailyFirst dosing with 800 mg/kg Drug a following a nonexposure Element14 days after start of ElementP14D

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

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Nametx
Dataset2
Concentration of Intervention ArticleConcentration Unit for Intervention Article
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 between2SPGRPCDApplicant-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 between5ITVCONCTRTDOSDose Level0
6TDM5TX1Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between6ITVCONCUTRTDOSUDose 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, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between8ARMCDArm Code2
9TDM5TX2Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between9SPGRPCDApplicant-Defined Group Code2
10TDM5TX2Group 2, (Intervention 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, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between11ITVCONCConcentration of Intervention ArticleSEE PROTOCOL
12TDM5TX2Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between12ITVCONCUConcentration Unit for Intervention ArticleSEE PROTOCOL
13TDM5TX2Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between13SPLANSUBPlanned Number of Subjects20
14TDM5TX3Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between14ARMCDArm Code3
15TDM5TX3Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between15SPGRPCDApplicant-Defined Group Code3
16TDM5TX3Group 3, (Intervention 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, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between17ITVCONCConcentration of Intervention ArticleSEE PROTOCOL
18TDM5TX3Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between18ITVCONCUConcentration Unit for Intervention ArticleSEE PROTOCOL
19TDM5TX3Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between19SPLANSUBPlanned Number of Subjects20
20TDM5TX4Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between20ARMCDArm Code4
21TDM5TX4Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between21SPGRPCDApplicant-Defined Group Code4
22TDM5TX4Group 4, (Intervention 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, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between23ITVCONCConcentration of Intervention ArticleSEE PROTOCOL
24TDM5TX4Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between24ITVCONCUConcentration Unit for Intervention ArticleSEE PROTOCOL
25TDM5TX4Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between25SPLANSUBPlanned Number of Subjects20