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) |
