Table 1.
Baseline demographics*
| Characteristic, n (%) | RCT pool†: ibrutinib ± BR N = 756 | RCT pool†: comparators N = 749 | Total ibrutinib pool N = 1768 |
|---|---|---|---|
| Age | |||
| <65 years | 274 (36) | 288 (38) | 758 (43) |
| 67–75 years | 352 (47) | 331 (44) | 726 (41) |
| >75 years | 130 (17) | 130 (17) | 284 (16) |
| Male | 508 (67) | 506 (68) | 1236 (70) |
| ECOG PS >1 | 13 (2) | 13 (2) | 62 (4) |
| Baseline platelet count | |||
| <50 × 109/l | 32 (4) | 20 (3) | 102 (6) |
| 50–100 × 109/l | 176 (23) | 179 (24) | 406 (23) |
| >100 × 109/l | 545 (72) | 547 (73) | 1256 (71) |
| Lymphocyte count ≥100 × 109/l | 128 (17) | 158 (21) | 221 (13) |
| Use of AC and/or AP‡ | 373 (49) | 359 (48) | 879 (50) |
| Any use of AC | 164 (22) | 145 (19) | 356 (20) |
| Any use of AP | 292 (39) | 276 (37) | 693 (39) |
| Use of both AC and AP | 83 (11) | 62 (8) | 170 (10) |
| Use of strong/moderate CYP3A inhibitor‡ | 241 (32) | 233 (31) | 541 (31) |
| History of bleeding events | 62 (8) | 55 (7) | 261 (15) |
| History of hypertension | 332 (44) | 329 (44) | 807 (46) |
| History of haemorrhagic stroke/TBI | 0 | 0 | 0 |
| History of alcohol abuse | 0 | 3 (0.4) | 4 (0.2) |
| Baseline INR | |||
| Total INR available | 722 (96) | 704 (94) | 1224 (69) |
| Abnormal (>1.5) | 9 (1) | 12 (2) | 14 (1) |
| Normal (≤1.5) | 713 (99) | 692 (92) | 1210 (99) |
AC, anticoagulant; AP, antiplatelet; BR, bendamustine, rituximab; ECOG PS, Eastern Cooperative Oncology Group performance status; INR, international normalised ratio; MH, major haemorrhage; RCT, randomised controlled trial; TBI, traumatic brain injury.
Including common baseline risk factors for MH.
Data from RESONATE (PCYC‐1112, ibrutinib [n = 195] vs. ofatumumab [n = 191]), RESONATE‐2 (PCYC‐1115, ibrutinib [n = 135] vs. chlorambucil [n = 132]), HELIOS (CLL3001, ibrutinib + BR vs. BR alone; n = 287) and RAY (MCL3001, ibrutinib vs. temsirolimus; n = 139) (Byrd et al, 2014; Burger et al, 2015; Chanan‐Khan et al, 2016; (Dreyling et al, 2016).
Concomitant use of AC, AP, or CYP3A inhibitor with ibrutinib or comparator (at any time during safety evaluation period, including 30 days after end of ibrutinib treatment for those without MH, or before onset of first MH for those with MH) including a 7‐day grace period after end of use.