Table 2 Adverse events occurring in ≥15% of patients in any treatment group
C1 – Niraparib (n = 25) | C2- Niraparib + Dostarlimab (n = 22) | |||
---|---|---|---|---|
AE detail | Grade ≥ 3 | Total | Grade ≥ 3 | Total |
Nausea | 0 (0%) | 14 (56%) | 1 (5%) | 13 (59%) |
Fatigue | 5 (20%) | 15 (60%) | 1 (5%) | 11 (50%) |
Dyspnoea | 0 (0%) | 11 (44%) | 2 (9%) | 13 (59%) |
Anaemia | 7 (28%) | 12 (48%) | 6 (27%) | 9 (41%) |
Constipation | 0 (0%) | 11 (44%) | 0 (0%) | 5 (23%) |
Dizziness | 0 (0%) | 6 (24%) | 0 (0%) | 9 (41%) |
Vomiting | 0 (0%) | 8 (32%) | 0 (0%) | 8 (36%) |
Creatinine increased | 0 (0%) | 6 (24%) | 0 (0%) | 7 (32%) |
Anorexia | 0 (0%) | 7 (28%) | 0 (0%) | 5 (23%) |
Cough | 0 (0%) | 4 (16%) | 0 (0%) | 7 (32%) |
Palpitations | 0 (0%) | 4 (16%) | 0 (0%) | 7 (32%) |
Platelet count decrease | 4 (16%) | 5 (20%) | 2 (9%) | 6 (27%) |
Diarrhoea | 0 (0%) | 4 (16%) | 0 (0%) | 5 (23%) |
Abdominal pain | 1 (4%) | 5 (20%) | 0 (0%) | 4 (18%) |
Insomnia | 0 (0%) | 5 (20%) | 0 (0%) | 4 (18%) |
Gastroesophageal reflux | 0 (0%) | 2 (8%) | 0 (0%) | 6 (27%) |
Headache | 0 (0%) | 6 (24%) | 0 (0%) | 2 (9%) |
Hypertension | 2 (8%) | 6 (24%) | 1 (5%) | 2 (9%) |
Neutrophil count decreased | 1 (4%) | 3 (12%) | 3 (14%) | 4 (18%) |
Hyponatremia | 2 (8%) | 6 (24%) | 0 (0%) | 1 (5%) |
Back pain | 0 (0%) | 5 (20%) | 0 (0%) | 2 (9%) |
Bloating | 0 (0%) | 1 (4%) | 0 (0%) | 5 (23%) |
White blood cell decreased | 0 (0%) | 4 (16%) | 1 (5%) | 2 (9%) |
Myalgia | 0 (0%) | 0 (0%) | 1 (5%) | 5 (23%) |
Hypomagnesemia | 0 (0%) | 4 (16%) | 0 (0%) | 1 (5%) |