Table 1.
Patient disposition
| Patient status, n (%) | Ibrutinib+BR (n = 289) | Placebo+BR (n = 289) | Total (N = 578) |
|---|---|---|---|
| Median months on study (95% CI) | 35.1 (33.7–35.9) | 34.5 (33.8–35.5) | 34.8 (34.1–35.5) |
| Study treatment phase disposition, n (%) | |||
| Did not receive study drug | 2 (0.7) | 2 (0.7) | 4 (0.7) |
| Ongoing | 171 (59.2) | 0 | 171 (29.6) |
| Discontinued study treatment | 116 (40.1) | 287 (99.3) | 403 (69.7) |
| Primary reason for discontinuationa | |||
| Adverse event | 47 (16.3) | 34 (11.8) | 81 (14.0) |
| Death | 14 (4.8) | 9 (3.1) | 23 (4.0) |
| Lost to follow-up | 1 (0.3) | 1 (0.3) | 2 (0.3) |
| Progressive disease or relapse | 27 (9.3) | 148 (51.2) | 175 (30.3) |
| Investigator or sponsor decision | 9 (3.1) | 83 (28.7) | 92 (15.9) |
| Withdrawal of consent | 20 (6.9) | 14 (4.8) | 34 (5.9) |
| Follow-up phase disposition, n (%) | |||
| In follow-up phase | 46 (15.9) | 194 (67.1) | 240 (41.5) |
| Post-treatment, prior to follow-up visitb,c | 4 (1.4) | 1 (0.3) | 5 (0.9) |
| Pre-progressive disease follow-up | 14 (4.8) | 47 (16.3) | 61 (10.6) |
| Post-progressive disease follow-up | 28 (9.7) | 146 (50.5) | 174 (30.1) |
| Crossover to ibrutinibc | 160 (55.4) | ||
| Death during crossover period | 23 (8.0) | ||
| Discontinued study | 72 (24.9) | 95 (32.9) | 167 (28.9) |
| Primary reason for discontinuation | |||
| Withdrawal of consent | 16 (5.5) | 21 (7.3) | 37 (6.4) |
| Lost to follow-up | 5 (1.7) | 2 (0.7) | 7 (1.2) |
| Death | 51 (17.6) | 72 (24.9) | 123 (21.3) |
BR bendamustine and rituximab, CI confidence interval
aIncludes patients who did not receive study medication
bA patient is counted here if the patient discontinued treatment but did not discontinue the study and did not yet have a first follow-up visit at the time of clinical cutoff
cCrossover patients may also be counted under the “post-treatment, prior to follow-up visit” category