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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:
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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 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 Type | 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 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 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 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 Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 11 | TRTDOS | Dose Level | SEE PROTOCOL | | 12 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 12 | TRTDOSU | Dose Units | SEE PROTOCOL | | 13 | TDM5 | TX | 2 | Group 2, (Compound 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 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 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 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 Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 17 | TRTDOS | Dose Level | SEE PROTOCOL | | 18 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 18 | TRTDOSU | Dose Units | SEE PROTOCOL | | 19 | TDM5 | TX | 3 | Group 3, (Compound 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 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 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 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 Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 23 | TRTDOS | Dose Level | SEE PROTOCOL | | 24 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 24 | TRTDOSU | Dose Units | SEE PROTOCOL | | 25 | TDM5 | TX | 4 | Group 4, (Compound 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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