Olaparib SOLO2/ENGOT-Ov21 (n = 195) [51] | Niraparib NOVA/ENGOT-OV16 (n = 367) [52] | Veliparib (n = 50) [55] | |||
---|---|---|---|---|---|
Grade 3 and 4 Adverse Events | Hematological | Anemia 38 (18%) Neutropenia 8 (4%) Thrombocytopenia 2 (1%) | Anemia 93 (25.3%) Neutropenia 72 (19.6%) Thrombocytopenia 124 (33.8%) | Anemia 45 (22%)/70 (19%) Neutropenia 16 (7%)/25 (7%) Thrombocytopenia 5 (2%)/19 (5%) | Leukopenia 1 (2%) Neutropenia 1 (2%) Thrombocytopenia 1 (2%) |
Non-hematological | Fatigue 8 (4%) Abdominal pain 5 (3%) Nausea 5 (3%) Vomiting 5 (3%) | Hypertension 30 (8.2%) Fatigue 30 (8.2%) Abdominal pain 4 (1.1%) Nausea 11 (3.0%) | Elevated AST/ALT 25 (13%)/39 (10%) Fatigue 18 (9%)/25 (7%) Abdominal pain 5 (2%)/9 (2%) Nausea 9 (4%)/14 (4%) | Nausea 2 (4%) Metabolism/nutrition 1 (2%) Other investigations 6 (12%) | |
Serious Adverse Events | Total | 35 (18%) | Total 110 (30%) [16] | ARIEL2: total 50 (25%) ARIEL3: total 78 (21%) | Total 12 (24%) |
Individual | Anemia 7 (4%) Abdominal pain 3 (2%) Intestinal obstruction 3 (2%) | ARIEL2: Intestinal obstruction 10 (5%) Anemia 9 (4%) ARIEL3: Anemia 16 (4%) Pyrexia 6 (2%) Vomiting 6 (2%) Intestinal obstruction 3 (1%) | |||
Dose Changes due to Adverse Events | Dose reductions 49 (25%) Discontinuations 21 (11%) | Dose reductions: 244 (66.5%) Discontinuations: 54 (14.7%) | ARIEL2: Dose reductions: 80 (39%) Discontinuations: 19 (9%) ARIEL3: Dose reductions: 203 (55%) Discontinuations: 50 (13%) | Dose Reductions: 31 (62%) Discontinuations: 31 (62%)a |