Table 2.
Adverse events
| Safety | Total |
|---|---|
| Total no. of AEs* | 236 |
| Patients receiving obinutuzumab and venetoclax with ≥1 AE | 12 (100.0) |
| Total no. of grade 3/4 AEs | 30 |
| Patients receiving obinutuzumab and venetoclax with ≥1 grade 3-4 AE | 10 (83.3) |
| Patients receiving obinutuzumab and venetoclax (n) | 12 |
| Neutropenia | |
| Any grade | 8 (66.7) |
| Grade 3-4 | 7 (58.3) |
| Febrile neutropenia | |
| Any grade | 3 (25.0) |
| Grade 3-4 | 3 (25.0) |
| Infections | |
| Any grade | 8 (66.7)† |
| Grade 3-4 | 2 (16.7)‡ |
| Bradycardia | |
| Any grade | 1 (8.3) |
| Grade 3-4 | 1 (8.3) |
| Diarrhea | |
| Any grade | 6 (50.0) |
| Grade 3-4 | 1 (8.3) |
| Hyperglycemia | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 1 (8.3) |
| IRR | |
| Any grade | 9 (75.0) |
| Grade 3-4 | 1 (8.3) |
| Leukopenia | |
| Any grade | 1 (8.3) |
| Grade 3-4 | 1 (8.3) |
| Myocardial infarction | |
| Any grade | 1 (8.3) |
| Grade 3-4 | 1 (8.3) |
| Presyncope | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 1 (8.3) |
| Pyrexia | |
| Any grade | 4 (33.3) |
| Grade 3-4 | 1 (8.3) |
| Syncope | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 2 (16.7) |
| Thrombocytopenia | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 2 (16.7) |
| Laboratory TLS | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 2 (16.7) |
| Transaminases increased | |
| Any grade | 2 (16.7) |
| Grade 3-4 | 1 (8.3) |
| Pruritus | |
| Any grade | 7 (58.3) |
| Grade 3-4 | 0 (0.0) |
| Cough | |
| Any grade | 6 (50.0) |
| Grade 3-4 | 0 (0.0) |
| Constipation | |
| Any grade | 5 (41.7) |
| Grade 3-4 | 0 (0.0) |
| Hyperkalemia | |
| Any grade | 5 (41.7) |
| Grade 3-4 | 0 (0.0) |
| Dizziness | |
| Any grade | 4 (33.3) |
| Grade 3-4 | 0 (0.0) |
| Nausea | |
| Any grade | 4 (33.3) |
| Grade 3-4 | 0 (0.0) |
| Back pain | |
| Any grade | 3 (25.0) |
| Grade 3-4 | 0 (0.0) |
| Fatigue | |
| Any grade | 3 (25.0) |
| Grade 3-4 | 0 (0.0) |
| Headache | |
| Any grade | 3 (25.0) |
| Grade 3-4 | 0 (0.0) |
| Vomiting | |
| Any grade | 3 (25.0) |
| Grade 3-4 | 0 (0.0) |
Values represent number (percentage) of patients unless otherwise indicated.
*
This table includes all grade 3-4 AEs regardless of frequency and AEs of any grade observed in at least 3 patients.
†
Including 2 cases of influenza infections, 2 upper respiratory tract infections, 1 respiratory infection, 1 urinary tract infection, 1 case of bronchitis, 1 case of cystitis, 1 ear infection, 1 eye infection, 1 localized infection, 1 case of oral herpes, 1 case of paronychia, 1 case of pneumonia, 1 case of rhinitis, and 1 skin infection.
‡
Including 1 case of influenza and 1 respiratory tract infection.