Patient disposition
| Characteristic . | Duvelisib . | Ofatumumab . |
|---|---|---|
| Randomized, n | 160 | 159 |
| Treated, n | 158 | 155 |
| Median exposure, wk | 50 | 23 |
| Discontinued treatment, n (%) | 124 (79) | 155 (100) |
| AE | 55 (35) | 6 (4) |
| Disease progression | 35 (22) | 31 (20) |
| Subject withdrawal | 13 (8) | 7 (5) |
| Death | 12 (8) | 3 (2) |
| Investigator decision | 3 (2) | 4 (3) |
| Completed treatment per protocol | 1 (1)* | 103 (67)* |
| Other | 5 (3) | 1 (1) |
| On treatment, n (%) | 34 (22) | 0 |
| Crossed over to study IPI-145-12 to receive opposite treatment, n (%) | 8 (5) | 89 (57) |
| Characteristic . | Duvelisib . | Ofatumumab . |
|---|---|---|
| Randomized, n | 160 | 159 |
| Treated, n | 158 | 155 |
| Median exposure, wk | 50 | 23 |
| Discontinued treatment, n (%) | 124 (79) | 155 (100) |
| AE | 55 (35) | 6 (4) |
| Disease progression | 35 (22) | 31 (20) |
| Subject withdrawal | 13 (8) | 7 (5) |
| Death | 12 (8) | 3 (2) |
| Investigator decision | 3 (2) | 4 (3) |
| Completed treatment per protocol | 1 (1)* | 103 (67)* |
| Other | 5 (3) | 1 (1) |
| On treatment, n (%) | 34 (22) | 0 |
| Crossed over to study IPI-145-12 to receive opposite treatment, n (%) | 8 (5) | 89 (57) |
Completed treatment of ofatumumab = 7 cycles and for duvelisib = 18 cycles (duvelisib-treated patients permitted to receive duvelisib ≥18 cycles).