Most common AEs
| Common AEs by SOC and PT . | Incidence, % . | Exposure-adjusted incidence rate∗ . | ||||||
|---|---|---|---|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |||||
| Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | |
| Blood and lymphatic system disorders | ||||||||
| Anemia | 22 | 19 | 12 | 13 | 1.2 | 1.2 | 0.6 | 0.6 |
| Neutropenia | 21 | 25 | 20 | 23 | 1.7 | 1.9 | 1.4 | 1.5 |
| Thrombocytopenia | 15 | 13 | 10 | 7 | 0.8 | 0.7 | 0.5 | 0.3 |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 35 | 46† | 1 | 5† | 1.9 | 2.8 | <0.1 | 0.2 |
| Nausea | 18 | 19 | 0 | <1 | 0.9 | 0.8 | 0 | <0.1 |
| Constipation | 12 | 14 | 0 | 1 | 0.5 | 0.6 | 0 | <0.1 |
| Vomiting | 11 | 14 | <1 | 1 | 0.4 | 0.5 | <0.1 | <0.1 |
| Dyspepsia | 4 | 12† | 0 | 0 | 0.1 | 0.5 | 0 | 0 |
| General disorders, administration site conditions, and injury | ||||||||
| Pyrexia | 23 | 19 | 3 | 1 | 1.1 | 1.0 | 0.1 | <0.1 |
| Fatigue | 20 | 17 | 3† | 0 | 0.9 | 0.9 | 0.1 | 0 |
| Peripheral edema | 10 | 14 | 0 | <1 | 0.5 | 0.6 | 0 | <0.1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 16 | 23† | 0 | 1 | 0.6 | 1.3 | 0 | <0.1 |
| Myalgia | 9 | 10 | 1 | <1 | 0.4 | 0.5 | <0.1 | <0.1 |
| Back pain | 8 | 13† | 0 | 1 | 0.3 | 0.5 | 0 | <0.1 |
| Muscle spasms | 6 | 13† | 0 | 1 | 0.2 | 0.7 | 0 | <0.1 |
| Nervous system disorders | ||||||||
| Headache | 35† | 20 | 2† | 0 | 1.8 | 1.1 | <0.1 | 0 |
| Dizziness | 11 | 10 | 0 | 0 | 0.5 | 0.5 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||||||
| Cough | 29† | 21 | 1 | <1 | 1.3 | 1.1 | <0.1 | <0.1 |
| Dyspnea | 14 | 9 | 2 | <1 | 0.5 | 0.4 | 0.1 | <0.1 |
| Common AEs by SOC and PT . | Incidence, % . | Exposure-adjusted incidence rate∗ . | ||||||
|---|---|---|---|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |||||
| Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | Acala n = 266 . | Ibru n = 263 . | |
| Blood and lymphatic system disorders | ||||||||
| Anemia | 22 | 19 | 12 | 13 | 1.2 | 1.2 | 0.6 | 0.6 |
| Neutropenia | 21 | 25 | 20 | 23 | 1.7 | 1.9 | 1.4 | 1.5 |
| Thrombocytopenia | 15 | 13 | 10 | 7 | 0.8 | 0.7 | 0.5 | 0.3 |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 35 | 46† | 1 | 5† | 1.9 | 2.8 | <0.1 | 0.2 |
| Nausea | 18 | 19 | 0 | <1 | 0.9 | 0.8 | 0 | <0.1 |
| Constipation | 12 | 14 | 0 | 1 | 0.5 | 0.6 | 0 | <0.1 |
| Vomiting | 11 | 14 | <1 | 1 | 0.4 | 0.5 | <0.1 | <0.1 |
| Dyspepsia | 4 | 12† | 0 | 0 | 0.1 | 0.5 | 0 | 0 |
| General disorders, administration site conditions, and injury | ||||||||
| Pyrexia | 23 | 19 | 3 | 1 | 1.1 | 1.0 | 0.1 | <0.1 |
| Fatigue | 20 | 17 | 3† | 0 | 0.9 | 0.9 | 0.1 | 0 |
| Peripheral edema | 10 | 14 | 0 | <1 | 0.5 | 0.6 | 0 | <0.1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 16 | 23† | 0 | 1 | 0.6 | 1.3 | 0 | <0.1 |
| Myalgia | 9 | 10 | 1 | <1 | 0.4 | 0.5 | <0.1 | <0.1 |
| Back pain | 8 | 13† | 0 | 1 | 0.3 | 0.5 | 0 | <0.1 |
| Muscle spasms | 6 | 13† | 0 | 1 | 0.2 | 0.7 | 0 | <0.1 |
| Nervous system disorders | ||||||||
| Headache | 35† | 20 | 2† | 0 | 1.8 | 1.1 | <0.1 | 0 |
| Dizziness | 11 | 10 | 0 | 0 | 0.5 | 0.5 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||||||||
| Cough | 29† | 21 | 1 | <1 | 1.3 | 1.1 | <0.1 | <0.1 |
| Dyspnea | 14 | 9 | 2 | <1 | 0.5 | 0.4 | 0.1 | <0.1 |
Common AEs were those occurring in ≥10% of patients in either treatment arm that were not already captured as an ECI.
Acala, acalabrutinib; Ibru, ibrutinib; PT, preferred term; SOC, system organ class.
Reported as events per 100 person-months.
2-sided P value < .05 without multiplicity adjustment, for comparison of incidence based on the Barnard exact test (indicated in bold).