Table 3.
Treatment-emergent adverse events (TEAE) of interest
| n (%) | Retrospective n = 153 |
Prospective n = 73 |
|
|---|---|---|---|
| Before inclusiona | After inclusion | ||
| Patients with TEAEs (any grade) | |||
| ≥ 1 TEAE | – | 128 (83.7) | 73 (100) |
| ≥ 1 TEAE related to ibrutinib | 114 (74.5) | 99 (64.7) | 62 (84.9) |
| ≥ 1 severe TEAEb | – | 61 (39.9) | 44 (60.3) |
| ≥ 1 serious TEAEc | – | 67 (43.8) | 43 (58.9) |
| ≥ 1 serious TEAE related to ibrutinib | 16 (10.5) | 36 (23.5) | 15 (20.5) |
| ≥ 1 TEAE leading to drug withdrawald | – | 30 (19.6) | 19 (26.0) |
| ≥ 1 TEAE leading to death | – | 19 (12.4) | 14 (19.2) |
| Patients with treatment-emergent bleeding events | |||
| ≥ 1 bleeding event | – | 46 (30.1) | 36 (49.3) |
| ≥ 1 major bleeding eventc | – | 5 (3.3) | 4 (5.5) |
| ≥ 1 bleeding event while on antithrombotic treatmentd | – | 18 (42.9) | 22 (78.6) |
| ≥ 1 bleeding event while not on antithrombotic treatmente | 28 (25.2) | 14 (31.1) | |
| ≥ 1 major bleeding event while on antithrombotic treatmente,f | – | 0 | 3 (10.7) |
| ≥ 1 major bleeding event while not on antithrombotic treatmente,f | 4 (3.6) | 0 | |
| Patients with ≥ 1 TEAE of interest (any grade) | |||
| Infectiong | – | 92 (60.1) | 49 (67.1) |
| Hypertension | – | 15 (9.8) | 12 (16.4) |
| Arrhythmiag | – | 15 (9.8) | 16 (21.9) |
| Atrial fibrillation | – | 11 (7.2) | 9 (12.3) |
| Arrhythmia | – | 0 | 4 (5.5) |
| Arthralgia/Myalgiag | – | 12 (7.8) | 18 (24.7) |
| Arthralgia | – | 7 (4.6) | 15 (20.5) |
| Myalgia | – | 5 (3.3) | 7 (9.6) |
| Diarrhea | – | 16 (10.5) | 15 (20.5) |
| Rashg | – | 12 (7.8) | 11 (15.1) |
TEAE treatment-emergent adverse event
aFor retrospectively included patients, only reported ibrutinib-related adverse events were recorded from the period prior to inclusion in the study
bSevere TEAE: on a scale of mild/moderate/severe and usually requires medical assistance/intervention/therapy and may require hospitalization
cSerious TEAE: life threatening or causing death
dWithdrawal includes any discontinuations that are related or unrelated to ibrutinib therapy, including death, toxicity, comorbidities, progressive disease and physician preference
eMajor bleeding is a severe/serious bleeding event
fPercentages are calculated based on the numbers of patients with and without concomitant antithrombotic therapy in the retrospective group (42 and 111, respectively) and in the prospective group (28 and 45, respectively)
gGrouped terms