Table 3.
Prevalence of most common (≥10% of patients) TEAEs (any grade) for ibrutinib+BR-randomized patients
| n (%) | 0–1 year (n = 287) | 1–2 years (n = 219) | 2–3 years (n = 188) | 3–4 years (n = 79) | Overall (N = 287) |
|---|---|---|---|---|---|
| Patients with any TEAE | 278 (96.9) | 185 (84.5) | 156 (83.0) | 62 (78.5) | 282 (98.3) |
| TEAEs reported in ≥10% of patients | |||||
| Neutropenia | 164 (57.1) | 43 (19.6) | 9 (4.8) | 0 | 167 (58.2) |
| Diarrhea | 98 (34.1) | 39 (17.8) | 21 (11.2) | 7 (8.9) | 110 (38.3) |
| Nausea | 105 (36.6) | 9 (4.1) | 7 (3.7) | 1 (1.3) | 106 (36.9) |
| Thrombocytopenia | 86 (30.0) | 10 (4.6) | 7 (3.7) | 3 (3.8) | 89 (31.0) |
| Anemia | 64 (22.3) | 5 (2.3) | 5 (2.7) | 1 (1.3) | 68 (23.7) |
| Pyrexia | 69 (24.0) | 11 (5.0) | 6 (3.2) | 0 | 78 (27.2) |
| Cough | 48 (16.7) | 25 (11.4) | 21 (11.2) | 4 (5.1) | 65 (22.6) |
| Fatigue | 58 (20.2) | 18 (8.2) | 16 (8.5) | 8 (10.1) | 67 (23.3) |
| Pneumonia | 38 (13.2) | 20 (9.1) | 16 (8.5) | 1 (1.3) | 61 (21.3) |
| Upper respiratory tract infection | 38 (13.2) | 24 (11.0) | 10 (5.3) | 2 (2.5) | 61 (21.3) |
| Bronchitis | 33 (11.5) | 15 (6.8) | 11 (5.9) | 2 (2.5) | 50 (17.4) |
| Sinusitis | 22 (7.7) | 14 (6.4) | 11 (5.9) | 0 | 33 (11.5) |
| Nasopharyngitis | 21 (7.3) | 13 (5.9) | 4 (2.1) | 1 (1.3) | 30 (10.5) |
| Constipation | 53 (18.5) | 13 (5.9) | 14 (7.4) | 5 (6.3) | 57 (19.9) |
| Rash | 45 (15.7) | 23 (10.5) | 9 (4.8) | 4 (5.1) | 56 (19.5) |
| Infusion-related reaction | 48 (16.7) | 0 | 0 | 0 | 48 (16.7) |
| Headache | 41 (14.3) | 11 (5.0) | 8 (4.3) | 6 (7.6) | 45 (15.7) |
| Vomiting | 40 (13.9) | 3 (1.4) | 2 (1.1) | 0 | 42 (14.6) |
| Edema peripheral | 32 (11.1) | 16 (7.3) | 13 (6.9) | 7 (8.9) | 42 (14.6) |
| Muscle spasms | 34 (11.8) | 17 (7.8) | 20 (10.6) | 7 (8.9) | 40 (13.9) |
| Decreased appetite | 35 (12.2) | 9 (4.1) | 2 (1.1) | 0 | 38 (13.2) |
| Abdominal pain | 30 (10.5) | 8 (3.7) | 7 (3.7) | 2 (2.5) | 37 (12.9) |
| Arthralgia | 28 (9.8) | 19 (8.7) | 11 (5.9) | 3 (3.8) | 37 (12.9) |
| Febrile neutropenia | 32 (11.1) | 2 (0.9) | 2 (1.1) | 0 | 36 (12.5) |
| Back pain | 29 (10.1) | 8 (3.7) | 10 (5.3) | 3 (3.8) | 36 (12.5) |
| Hypertension | 23 (8.0) | 20 (9.1) | 20 (10.6) | 7 (8.9) | 35 (12.2) |
| Hyperuricemia | 27 (9.4) | 7 (3.2) | 10 (5.3) | 3 (3.8) | 35 (12.2) |
| Chills | 31 (10.8) | 3 (1.4) | 2 (1.1) | 0 | 33 (11.5) |
| Pruritus | 29 (10.1) | 11 (5.0) | 7 (3.7) | 2 (2.5) | 32 (11.1) |
BR bendamustine and rituximab, TEAE treatment-emergent adverse event