Table 2.
Treatment-emergent adverse events (≥ 3 patients in any grade, FAS)
| Adverse events, n (%) | Venetoclax + Obinutuzumab N = 10 |
|
|---|---|---|
| Any grade | Grade 3 or 4 | |
| Patients with any event | 10 (100.0) | 8 (80.0) |
| Patients with neutropenia or neutrophil count decreased | 8 (80.0) | 8 (80.0) |
| Blood and lymphatic system disorders | ||
| Anemia | 3 (30.0) | 1 (10.0) |
| Leukopenia | 3 (30.0) | 3 (30.0) |
| Lymphopenia | 3 (30.0) | 3 (30.0) |
| Neutropeniaa | 3 (30.0) | 3 (30.0) |
| Gastrointestinal disorders | ||
| Constipation | 3 (30.0) | 0 (0.0) |
| Diarrhea | 3 (30.0) | 0 (0.0) |
| Nausea | 4 (40.0) | 0 (0.0) |
| General disorders and administration site conditions | ||
| Pyrexia | 3 (30.0) | 0 (0.0) |
| Infections and infestations | ||
| COVID-19 | 3 (30.0) | 0 (0.0) |
| Injury, poisoning and procedural complications | ||
| Infusion related reaction | 6 (60.0) | 1 (10.0) |
| Investigations | ||
| Neutrophil count decreased | 5 (50.0) | 5 (50.0) |
| Platelet count decreased | 3 (30.0) | 3 (30.0) |
Adverse events were classified by System Organ Class and coded using Preferred Terms according to MedDRA version 26.1
FAS, full analysis set; MedDRA, Medical Dictionary for Regulatory Activities
aIncluding a single case of febrile neutropenia