Table 3.
Most Common AEs in ≥10% (Any Grade) or ≥5% (Grade ≥3) of Patients in Any Cohort
| Common AEsa, n (%) | Acalabrutinib (n = 154) | IdR (n = 118) | BR (n = 35) | |||
|---|---|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Neutropenia | 37 (24) | 29 (19) | 55 (47) | 47 (40) | 12 (34) | 11 (31) |
| Headache | 36 (23) | 1 (1) | 7 (6) | 0 | 0 | 0 |
| Diarrhea | 33 (21) | 3 (2) | 62 (53) | 31 (26) | 5 (14) | 0 |
| Upper respiratory tract infection | 31 (20) | 3 (2) | 20 (17) | 4 (3) | 4 (11) | 1 (3) |
| Pneumonia | 30 (19) | 15 (10) | 17 (14) | 12 (10) | 2 (6) | 1 (3) |
| Anemia | 27 (18) | 20 (13) | 13 (11) | 8 (7) | 4 (11) | 3 (9) |
| Cough | 27 (18) | 0 | 18 (15) | 1 (1) | 2 (6) | 0 |
| Pyrexia | 25 (16) | 5 (3) | 23 (19) | 8 (7) | 6 (17) | 1 (3) |
| Arthralgia | 20 (13) | 2 (1) | 7 (6) | 0 | 1 (3) | 0 |
| Thrombocytopenia | 20 (13) | 6 (4) | 19 (16) | 10 (8) | 5 (14) | 1 (3) |
| Bronchitis | 19 (12) | 2 (1) | 9 (8) | 1 (1) | 3 (9) | 1 (3) |
| Fatigue | 19 (12) | 2 (1) | 10 (8) | 1 (1) | 8 (23) | 1 (3) |
| Respiratory tract infection | 18 (12) | 2 (1) | 8 (7) | 2 (2) | 0 | 0 |
| Nausea | 13 (8) | 0 | 17 (14) | 1 (1) | 7 (20) | 0 |
| Infusion-related reaction | 1 (1) | 0 | 9 (8) | 2 (2) | 8 (23) | 1 (3) |
| Rash | 15 (10) | 0 | 17 (14) | 4 (3) | 2 (6) | 0 |
| Nasopharyngitis | 13 (8) | 0 | 13 (11) | 0 | 1 (3) | 0 |
| Constipation | 14 (9) | 0 | 9 (8) | 0 | 5 (14) | 2 (6) |
aAEs were graded according to the Common Toxicity Criteria of the National Cancer Institute, version 4.03 and reported until 30 d after the last dose of study drug or at documented disease progression, whichever was longer.
AE = adverse event; BR = bendamustine plus rituximab; IdR = idelalisib plus rituximab.