Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
---|
1 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 1 | ARMCD | Arm Code | 01 |
2 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 2 | SPGRPCD | applicant-Defined Group Code | 1 |
3 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 3 | GRPLBL | Group Label | Group 1, Control |
4 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 4 | SETLBL | Set Label | Group 1, Control - Nonrec |
5 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 5 | TRTDOS | Dose Level | 0 |
6 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 6 | TRTDOSU | Dose Units | mg/kg/day |
7 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 7 | TCNTRL | Control TypeVehicle Control | VEHICLE CONTROL |
8 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 8 | PLANMSUB | Planned Number of Male Subjects | 5 |
9 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 9 | PLANFSUB | Planned Number of Female Subjects | 5 |
10 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 10 | ARMCD | Arm Code | 01R |
11 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 11 | SPGRPCD | Applicant-Defined Group Code | 1 |
12 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 12 | GRPLBL | Group Label | Group 1, Control |
13 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 13 | SETLBL | Set Label | Group 1, Control - Rec |
14 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 14 | TRTDOS | Dose Level | 0 |
15 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 15 | TRTDOSU | Dose Units | mg/kg/day |
16 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 16 | TCNTRL | Control TypeVehicle Control | VEHICLE CONTROL |
17 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 17 | PLANMSUB | Planned Number of Male Subjects | 5 |
18 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 18 | PLANFSUB | Planned Number of Female Subjects | 5 |
19 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 19 | ARMCD | Arm Code | 02 |
20 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 20 | SPGRPCD | Applicant-Defined Group Code | 2 |
21 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 21 | GRPLBL | Group Label | Group 2, 100 mg/kg |
22 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 22 | SETLBL | Set Label | Group 2, 100 mg/kg - Nonrec |
23 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 23 | TRTDOS | Dose Level | 100 |
24 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 24 | TRTDOSU | Dose Units | mg/kg/day |
25 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 25 | PLANMSUB | Planned Number of Male Subjects | 5 |
26 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 26 | PLANFSUB | Planned Number of Female Subjects | 5 |
27 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 27 | ARMCD | Arm Code | 02R |
28 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 28 | SPGRPCD | Applicant-Defined Group Code | 2 |
29 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 29 | GRPLBL | Group Label | Group 2, 100 mg/kg |
30 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 30 | SETLBL | Set Label | Group 2, 100 mg/kg - Rec |
31 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 31 | TRTDOS | Dose Level | 100 |
32 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 32 | TRTDOSU | Dose Units | mg/kg/day |
33 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 33 | PLANMSUB | Planned Number of Male Subjects | 5 |
34 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 34 | PLANFSUB | Planned Number of Female Subjects | 5 |
35 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 35 | ARMCD | Arm Code | 03 |
36 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 36 | SPGRPCD | Applicant-Defined Group Code | 3 |
37 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 37 | GRPLBL | Group Label | Group 3, 500 mg/kg |
38 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 38 | SETLBL | Set Label | Group 3, 500 mg/kg - Nonrec |
39 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 39 | TRTDOS | Dose Level | 500 |
40 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 40 | TRTDOSU | Dose Units | mg/kg/day |
41 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 41 | PLANMSUB | Planned Number of Male Subjects | 5 |
42 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 42 | PLANFSUB | Planned Number of Female Subjects | 5 |
43 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 43 | ARMCD | Arm Code | 03R |
44 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 44 | SPGRPCD | Applicant-Defined Group Code | 3 |
45 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 45 | GRPLBL | Group Label | Group 3, 500 mg/kg |
46 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 46 | SETLBL | Set Label | Group 3, 500 mg/kg - Rec |
47 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 47 | TRTDOS | Dose Level | 500 |
48 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 48 | TRTDOSU | Dose Units | mg/kg/day |
49 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 49 | PLANMSUB | Planned Number of Male Subjects | 5 |
50 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 50 | PLANFSUB | Planned Number of Female Subjects | 5 |