| 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 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 | DOS | ITVCONC | Concentration of Intervention ArticleDose 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 | ITVDOSU | ITVCONCU | Concentration Unit for Intervention ArticleDose 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, (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, (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, (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, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 11 | ITVDOS | ITVCONC | Concentration of Intervention ArticleDose Level | SEE PROTOCOL |
| 12 | TDM5 | TX | 2 | Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 12 | ITVDOSU | ITVCONCU | Concentration Unit for Intervention ArticleDose Units | SEE PROTOCOL |
| 13 | TDM5 | TX | 2 | Group 2, (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, (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, (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, (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, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 17 | ITVDOS | ITVCONC | Concentration of Intervention ArticleDose Level | SEE PROTOCOL |
| 18 | TDM5 | TX | 3 | Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 18 | ITVDOSU | ITVCONCU | Concentration Unit for Intervention ArticleDose Units | SEE PROTOCOL |
| 19 | TDM5 | TX | 3 | Group 3, (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, (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, (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, (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, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 23 | ITVDOS | ITVCONC | Concentration of Intervention ArticleDose Level | SEE PROTOCOL |
| 24 | TDM5 | TX | 4 | Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 24 | ITVDOSU | ITVCONCU | Concentration Unit for Intervention ArticleDose Units | SEE PROTOCOL |
| 25 | TDM5 | TX | 4 | Group 4, (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 |