Disposition of patients in the full analysis set (part 2)
| Disposition . | Arm 1 (IV-O-IV-O), n (%) . | Arm 2 (O-IV-O-IV, n (%) . | Total, n (%) . |
|---|---|---|---|
| FAS | 11 (100.0) | 11 (100.0) | 22 (100.0) |
| Evaluable | 11 (100.0) | 9 (81.8) | 20 (90.9) |
| PKAS, evaluable days∗ | 64 (72.7) | 52 (72.2) | 116 (72.5) |
| Cycle 1† | 15 (68.2) | 16 (88.9) | 31 (77.5) |
| Cycle 2 | 18 (81.8) | 13 (72.2) | 31 (77.5) |
| Cycle 3 | 14 (63.6) | 11 (61.1) | 25 (62.5) |
| Cycle 4 | 17 (77.3) | 12 (66.7) | 29 (72.5) |
| mPKAS, evaluable days∗ | 81 (92.0) | 64 (88.9) | 145 (90.6) |
| Cycle 1† | 21 (95.5) | 18 (100.0) | 39 (97.5) |
| Cycle 2 | 21 (95.5) | 16 (88.9) | 37 (92.5) |
| Cycle 3 | 20 (90.9) | 15 (83.3) | 35 (87.5) |
| Cycle 4 | 19 (86.4) | 15 (83.3) | 34 (85.0) |
| Completion of protocol treatment | 11 (100.0) | 10 (90.9) | 21 (95.5) |
| Discontinuation | 0 (0.0) | 1 (9.1) | 1 (4.5) |
| Investigator decision | 0 | 1 | 1 (4.5) |
| Events after discontinuation | |||
| Relapse | 1 | 0 | 1 (4.5) |
| Death | 0 | 0 | 0 (0) |
| Disposition . | Arm 1 (IV-O-IV-O), n (%) . | Arm 2 (O-IV-O-IV, n (%) . | Total, n (%) . |
|---|---|---|---|
| FAS | 11 (100.0) | 11 (100.0) | 22 (100.0) |
| Evaluable | 11 (100.0) | 9 (81.8) | 20 (90.9) |
| PKAS, evaluable days∗ | 64 (72.7) | 52 (72.2) | 116 (72.5) |
| Cycle 1† | 15 (68.2) | 16 (88.9) | 31 (77.5) |
| Cycle 2 | 18 (81.8) | 13 (72.2) | 31 (77.5) |
| Cycle 3 | 14 (63.6) | 11 (61.1) | 25 (62.5) |
| Cycle 4 | 17 (77.3) | 12 (66.7) | 29 (72.5) |
| mPKAS, evaluable days∗ | 81 (92.0) | 64 (88.9) | 145 (90.6) |
| Cycle 1† | 21 (95.5) | 18 (100.0) | 39 (97.5) |
| Cycle 2 | 21 (95.5) | 16 (88.9) | 37 (92.5) |
| Cycle 3 | 20 (90.9) | 15 (83.3) | 35 (87.5) |
| Cycle 4 | 19 (86.4) | 15 (83.3) | 34 (85.0) |
| Completion of protocol treatment | 11 (100.0) | 10 (90.9) | 21 (95.5) |
| Discontinuation | 0 (0.0) | 1 (9.1) | 1 (4.5) |
| Investigator decision | 0 | 1 | 1 (4.5) |
| Events after discontinuation | |||
| Relapse | 1 | 0 | 1 (4.5) |
| Death | 0 | 0 | 0 (0) |
FAS, full analysis set; O, oral.
The denominators for evaluable days in both the PKAS and mPKAS are: 11 × 4 × 2 = 88 in Arm 1, 9 × 4 × 2 = 72 in Arm 2, and 20 × 4 × 2 = 160 for the total.
The denominators for evaluable days in each cycle in both the PKAS and mPKAS are: 11 × 2 = 22 in arm 1, 9 × 2 = 18 in arm 2, and 20 × 2 = 40 for the total.