Table 1.
Patient disposition for the intent-to-treat population.
| Ibrutinib plus BR (n = 289) | Placebo plus BRa (n = 289) | Total (N = 578) | |
|---|---|---|---|
| Median time on study, months (95% CI) | 63.3 (62.1–64.4) | 64.0 (63.0–64.8) | 63.7 (62.8–64.3) |
| [Range] | [0.2–73.5] | [0.1–74.5] | [0.1–74.5] |
| Study treatment phase disposition, n (%) | |||
| Did not receive study drug | 2 (0.7) | 2 (0.7) | 4 (0.7) |
| Discontinued study treatment | 287 (99.3) | 287 (99.3) | 574 (99.3) |
| Primary reason for discontinuation,b n (%) | |||
| Investigator or sponsor decision (including end of follow-up on trial)c | 136 (47.1) | 84 (29.1) | 220 (38.1) |
| Progressive disease or relapse | 55 (19.0) | 148 (51.2) | 203 (35.1) |
| Adverse event | 58 (20.1) | 34 (11.8) | 92 (15.9) |
| Withdrawal of consent | 23 (8.0) | 13 (4.5) | 36 (6.2) |
| Death | 16 (5.5) | 9 (3.1) | 25 (4.3) |
| Lost to follow-up | 1 (0.3) | 1 (0.3) | 2 (0.3) |
| Crossover to ibrutinib | – | 183 (66.3) | – |
BR: bendamustine and rituximab; CI: confidence interval; TEAEs: treatment-emergent adverse events.
a
Following the prespecified interim analysis, placebo treatment was discontinued on 10 March 2015, as was the reporting of TEAEs for the placebo arm; these patients had continued disease evaluation and follow-up and were permitted to cross over to ibrutinib after confirmed disease progression.
b
Includes patients who did not receive study medication.
c
Includes patients who rolled over to the phase 3b access study (CAN3001) or commercial ibrutinib.