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This example assumes a crossover design in which the sponsorapplicant-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 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.
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| SENDIG:Figure. Example Trial 5 DesignSENDIG: |
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| 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.
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-216 |
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Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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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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Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
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1 | TDM5 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | ScreenPRE-EXPOSURE | 2 | TDM5 | TA | 1 | Control | 2 | CONTROL | Vehicle Control | Trt 1
| EXPOSURE | 3 | TDM5 | TA | 1 | Control | 3 | REST | Rest for 7 days | Rest 1
| WASHOUT | 4 | TDM5 | TA | 1 | Control | 4 | CONTROL | Vehicle Control | Trt 2
| EXPOSURE | 5 | TDM5 | TA | 1 | Control | 5 | REST | Rest for 7 days | Rest 2
| WASHOUT | 6 | TDM5 | TA | 1 | Control | 6 | CONTROL | Vehicle Control | Trt 3
| EXPOSURE | 7 | TDM5 | TA | 2 | 50-800-400 | 1 | SCRN | Screen | Randomized to Group 2 | ScreenPRE-EXPOSURE | 8 | TDM5 | TA | 2 | 50-800-400 | 2 | 50A | 50 mg/kg Drug A | Trt 1
| EXPOSURE | 9 | TDM5 | TA | 2 | 50-800-400 | 3 | REST | Rest for 7 days | Rest 1
| WASHOUT | 10 | TDM5 | TA | 2 | 50-800-400 | 4 | 800A | 800 mg/kg Drug A | Trt 2
| EXPOSURE | 11 | TDM5 | TA | 2 | 50-800-400 | 5 | REST | Rest for 7 days | Rest 2
| WASHOUT | 12 | TDM5 | TA | 2 | 50-800-400 | 6 | 400A | 400 mg/kg Drug A | Trt 3
| EXPOSURE | 13 | TDM5 | TA | 3 | 400-50-800 | 1 | SCRN | Screen | Randomized to Group 3 | ScreenPRE-EXPOSURE | 14 | TDM5 | TA | 3 | 400-50-800 | 2 | 400A | 400 mg/kg Drug A | Trt 1
| EXPOSURE | 15 | TDM5 | TA | 3 | 400-50-800 | 3 | REST | Rest for 7 days | Rest 1
| WASHOUT | 16 | TDM5 | TA | 3 | 400-50-800 | 4 | 50A | 50 mg/kg Drug A | Trt 2
| EXPOSURE | 17 | TDM5 | TA | 3 | 400-50-800 | 5 | REST | Rest for 7 days | Rest 2
| WASHOUT | 18 | TDM5 | TA | 3 | 400-50-800 | 6 | 800A | 800 mg/kg Drug A | Trt 3
| EXPOSURE | 19 | TDM5 | TA | 4 | 800-400-50 | 1 | SCRN | Screen | Randomized to Group 4 | ScreenPRE-EXPOSURE | 20 | TDM5 | TA | 4 | 800-400-50 | 2 | 800A | 800 mg/kg Drug A | Trt 1
| EXPOSURE | 21 | TDM5 | TA | 4 | 800-400-50 | 3 | REST | Rest for 7 days | Rest 1
| WASHOUT | 22 | TDM5 | TA | 4 | 800-400-50 | 4 | 400A | 400 mg/kg Drug A | Trt 2
| EXPOSURE | 23 | TDM5 | TA | 4 | 800-400-50 | 5 | REST | Rest for 7 days | Rest 2
| WASHOUT | 24 | TDM5 | TA | 4 | 800-400-50 | 6 | 50A | 50 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 exposure (vehicle control or compoundproduct) and sequencing of treatment exposure levels. The sponsor applicant is providing the arm code, sponsorapplicant-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.
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Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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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 | SponsorApplicant-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 | SponsorApplicant-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 | SponsorApplicant-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 | SponsorApplicant-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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