Table 2.
Number of Patients With Treatment-emergent Adverse Events
| TE (n = 6) | TEO (n = 30) | Total (N = 36) | |
|---|---|---|---|
| Serious TEAEs | 1 (16.7%) | 15 (50.0%) | 16 (44.4%) |
| Any TEAEs | 6 (100%) | 30 (100%) | 36 (100%) |
| Grade 2a | 4 (66.7%) | 8 (26.7%) | 12 (33.3%) |
| Grade 3a | 2 (33.3%) | 9 (30.0%) | 11 (30.6%) |
| Grade 4a | 0 | 11 (36.7%) | 11 (30.6%) |
| Grade 5a | 0 | 2 (6.7%) | 2 (5.6%) |
| Relatedness of TEAEs | |||
| Related to tirabrutinib | 3 (50.0%) | 27 (90.0%) | 30 (83.3%) |
| Related to entospletinib | 2 (33.3%) | 26 (86.7%) | 28 (77.8%) |
| Related to obinutuzumab | – | 22 (73.3%) | – |
| Most common TEAEs occurring in ≥20% of all patients | |||
| Neutropenia | 0 | 14 (46.7%) | 14 (38.9%) |
| Nasopharyngitis | 4 (66.7%) | 10 (33.3%) | 14 (38.9%) |
| Fatigue | 2 (33.3%) | 10 (33.3%) | 12 (33.3%) |
| Pyrexia | 1 (16.7%) | 10 (33.3%) | 11 (30.6%) |
| Nausea | 2 (33.3%) | 9 (30.0%) | 11 (30.6%) |
| Cough | 1 (16.7%) | 9 (30.0%) | 10 (27.8%) |
| Hematoma | 2 (33.3%) | 7 (23.3%) | 9 (25.0%) |
| Constipation | 0 | 8 (26.7%) | 8 (22.2%) |
| Diarrhea | 1 (16.7%) | 7 (23.3%) | 8 (22.2%) |
| Grade 3–5 TEAEs | 2 (33.3%) | 22 (73.3%) | 24 (66.7%) |
| Neutropenia | 0 | 13 (43.3%) | 13 (36.1%) |
| Urinary tract infection | 0 | 3 (10.0%) | 3 (8.3%) |
| Anemia | 1 (16.7%) | 2 (6.7%) | 3 (8.3%) |
| Infusion-related reaction | 0 | 2 (6.7%) | 2 (5.6%) |
| Leukopenia | 0 | 2 (6.7%) | 2 (5.6%) |
| Syncope | 0 | 2 (6.7%) | 2 (5.6%) |
| Benign prostatic hyperplasia | 0 | 1 (3.3%) | 1 (2.8%) |
| Bronchitis | 0 | 1 (3.3%) | 1 (2.8%) |
| Bronchopulmonary aspergillosis | 0 | 1 (3.3%) | 1 (2.8%) |
| Cataract | 0 | 1 (3.3%) | 1 (2.8%) |
| Chills | 0 | 1 (3.3%) | 1 (2.8%) |
| COVID-19 pneumonia | 0 | 1 (3.3%) | 1 (2.8%) |
| Disease progression | 0 | 1 (3.3%) | 1 (2.8%) |
| Headache | 0 | 1 (3.3%) | 1 (2.8%) |
| Hydrocele | 0 | 1 (3.3%) | 1 (2.8%) |
| Hypokalemia | 0 | 1 (3.3%) | 1 (2.8%) |
| Hyponatremia | 0 | 1 (3.3%) | 1 (2.8%) |
| Lipase increased | 0 | 1 (3.3%) | 1 (2.8%) |
| Nasopharyngitis | 0 | 1 (3.3%) | 1 (2.8%) |
| Neutrophil count decreased | 0 | 1 (3.3%) | 1 (2.8%) |
| Peripheral arterial occlusive disease | 0 | 1 (3.3%) | 1 (2.8%) |
| Peritonsillitis | 0 | 1 (3.3%) | 1 (2.8%) |
| Platelet count decreased | 0 | 1 (3.3%) | 1 (2.8%) |
| Pneumonia | 0 | 1 (3.3%) | 1 (2.8%) |
| Subdural hematoma | 0 | 1 (3.3%) | 1 (2.8%) |
| Thrombocytopenia | 0 | 1 (3.3%) | 1 (2.8%) |
| Tracheobronchitis | 0 | 1 (3.3%) | 1 (2.8%) |
| Hypertriglyceridemia | 1 (16.7%) | 0 | 1 (2.8%) |
| Procedural hemorrhage | 1 (16.7%) | 0 | 1 (2.8%) |
Data shown as n (%).
aMost severe TEAE per patient.
TE = combination of tirabrutinib and entospletinib; TEAE = treatment-emergent adverse event; TEO = triple combination therapy of tirabrutinib, entospletinib, and obinutuzumab.