Incidence (≥15%) of treatment-emergent AEs in the primary study (PCYC-1108), BR-ibrutinib cohort (N = 30)
| AE . | Any grade event, n (%) . | Grade ≥3, n (%) . |
|---|---|---|
| Hematologic AEs | ||
| Neutropenia | 12 (40.0) | 12 (40.0) |
| Febrile neutropenia | 2 (6.7) | 2 (6.7) |
| Thrombocytopenia | 5 (16.7) | 2 (6.7) |
| Nonhematologic AEs | ||
| Diarrhea | 21 (70.0) | 1 (3.3) |
| Nausea | 20 (66.7) | — |
| Fatigue | 14 (46.7) | 3 (10.0) |
| Upper respiratory tract infection | 11 (36.7) | 1 (3.3) |
| Edema, peripheral | 10 (33.3) | — |
| Eye disorders | 9 (30.0) | — |
| Constipation | 9 (30.0) | — |
| Vomiting | 9 (30.0) | 1 (3.3) |
| Headache | 9 (30.0) | — |
| Sinusitis | 8 (26.7) | 1 (3.3) |
| Arthralgia | 8 (26.7) | — |
| Pyrexia | 7 (23.3) | — |
| Muscle spasms | 7 (23.3) | — |
| Dizziness | 7 (23.3) | — |
| Insomnia | 7 (23.3) | — |
| Gastroesophageal reflux disease | 6 (20.0) | — |
| Contusion | 6 (20.0) | — |
| Squamous cell carcinoma | 6 (20.0) | — |
| Maculopapular rash | 5 (16.7) | 3 (10.0) |
| Chills | 5 (16.7) | — |
| Decreased appetite | 5 (16.7) | — |
| Back pain | 5 (16.7) | — |
| Myalgia | 5 (16.7) | — |
| AE . | Any grade event, n (%) . | Grade ≥3, n (%) . |
|---|---|---|
| Hematologic AEs | ||
| Neutropenia | 12 (40.0) | 12 (40.0) |
| Febrile neutropenia | 2 (6.7) | 2 (6.7) |
| Thrombocytopenia | 5 (16.7) | 2 (6.7) |
| Nonhematologic AEs | ||
| Diarrhea | 21 (70.0) | 1 (3.3) |
| Nausea | 20 (66.7) | — |
| Fatigue | 14 (46.7) | 3 (10.0) |
| Upper respiratory tract infection | 11 (36.7) | 1 (3.3) |
| Edema, peripheral | 10 (33.3) | — |
| Eye disorders | 9 (30.0) | — |
| Constipation | 9 (30.0) | — |
| Vomiting | 9 (30.0) | 1 (3.3) |
| Headache | 9 (30.0) | — |
| Sinusitis | 8 (26.7) | 1 (3.3) |
| Arthralgia | 8 (26.7) | — |
| Pyrexia | 7 (23.3) | — |
| Muscle spasms | 7 (23.3) | — |
| Dizziness | 7 (23.3) | — |
| Insomnia | 7 (23.3) | — |
| Gastroesophageal reflux disease | 6 (20.0) | — |
| Contusion | 6 (20.0) | — |
| Squamous cell carcinoma | 6 (20.0) | — |
| Maculopapular rash | 5 (16.7) | 3 (10.0) |
| Chills | 5 (16.7) | — |
| Decreased appetite | 5 (16.7) | — |
| Back pain | 5 (16.7) | — |
| Myalgia | 5 (16.7) | — |
Dashes represent the absence of grade 3 or higher AEs.