Incidence of AEs (>15% of patients overall or >5% ≥grade 3)
| AE category, SOC, PT . | All patients (all duvelisib doses) (N = 210), n (%) . | ||
|---|---|---|---|
| Grade | Any | 3 | 4 |
| Hematologic | |||
| Neutropenia | 81 (38.6) | 19 (9.0) | 23 (11.0) |
| Anemia | 52 (24.8) | 29 (13.8) | 1 (0.5) |
| Thrombocytopenia/decreased platelets | 49 (23.3) | 9 (4.3) | 21 (10.0) |
| Investigations | |||
| ALT increased | 81 (38.6) | 33 (15.7) | 8 (3.8) |
| AST increased | 79 (37.6) | 30 (14.3) | 2 (1.0) |
| Hypokalemia | 31 (14.8) | 5 (2.4) | 6 (2.9) |
| Nonhematologic | |||
| Diarrhea | 88 (41.9) | 24 (11.4) | 0 |
| Fatigue | 85 (40.5) | 17 (8.1) | 1 (0.5) |
| Pyrexia | 74 (35.2) | 3 (1.4) | 0 |
| Nausea | 67 (31.9) | 7 (3.3) | 0 |
| Cough | 66 (31.4) | 1 (0.5) | 0 |
| Decreased appetite | 44 (21.0) | 2 (1.0) | 0 |
| Edema peripheral | 43 (20.5) | 1 (0.5) | 0 |
| Dyspnea | 41 (19.5) | 9 (4.3) | 2 (1.0) |
| Headache | 38 (18.1) | 4 (1.9) | 0 |
| Vomiting | 37 (17.6) | 4 (1.9) | 0 |
| Arthralgia | 35 (16.7) | 4 (1.9) | 0 |
| Rash maculopapular | 34 (16.2) | 11 (5.2) | 0 |
| Upper respiratory tract infection | 34 (16.2) | 1 (0.5) | 0 |
| Rash | 30 (14.3) | 1 (0.5) | 0 |
| Constipation | 32 (15.2) | 1 (0.5) | 0 |
| Pneumonia | 28 (13.3) | 19 (9.0) | 1 (0.5) |
| AE category, SOC, PT . | All patients (all duvelisib doses) (N = 210), n (%) . | ||
|---|---|---|---|
| Grade | Any | 3 | 4 |
| Hematologic | |||
| Neutropenia | 81 (38.6) | 19 (9.0) | 23 (11.0) |
| Anemia | 52 (24.8) | 29 (13.8) | 1 (0.5) |
| Thrombocytopenia/decreased platelets | 49 (23.3) | 9 (4.3) | 21 (10.0) |
| Investigations | |||
| ALT increased | 81 (38.6) | 33 (15.7) | 8 (3.8) |
| AST increased | 79 (37.6) | 30 (14.3) | 2 (1.0) |
| Hypokalemia | 31 (14.8) | 5 (2.4) | 6 (2.9) |
| Nonhematologic | |||
| Diarrhea | 88 (41.9) | 24 (11.4) | 0 |
| Fatigue | 85 (40.5) | 17 (8.1) | 1 (0.5) |
| Pyrexia | 74 (35.2) | 3 (1.4) | 0 |
| Nausea | 67 (31.9) | 7 (3.3) | 0 |
| Cough | 66 (31.4) | 1 (0.5) | 0 |
| Decreased appetite | 44 (21.0) | 2 (1.0) | 0 |
| Edema peripheral | 43 (20.5) | 1 (0.5) | 0 |
| Dyspnea | 41 (19.5) | 9 (4.3) | 2 (1.0) |
| Headache | 38 (18.1) | 4 (1.9) | 0 |
| Vomiting | 37 (17.6) | 4 (1.9) | 0 |
| Arthralgia | 35 (16.7) | 4 (1.9) | 0 |
| Rash maculopapular | 34 (16.2) | 11 (5.2) | 0 |
| Upper respiratory tract infection | 34 (16.2) | 1 (0.5) | 0 |
| Rash | 30 (14.3) | 1 (0.5) | 0 |
| Constipation | 32 (15.2) | 1 (0.5) | 0 |
| Pneumonia | 28 (13.3) | 19 (9.0) | 1 (0.5) |
AEs were coded using Medical Dictionary for Regulatory Activities, version 16.1, and were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
PT, preferred term; SOC, system organ class.