Table 2

Safety summary for parts AD

Preferred term, n (%)Part A
DOS+NIR
Part B
DOS+C–P
Part C
DOS+NIR+BEV
Part D
DOS+C–P+BEV
Niraparib
200 mg QD
(n=16)
Niraparib
300 mg QD
(n=6)
Overall
(n=22)
Overall
(n=14)
Niraparib
200 mg QD
(n=6)
Niraparib
300 mg QD
(n=7)
Overall
(n=13)
Overall
(n=6)
Any-grade TEAEs*16 (100)6 (100)22 (100)14 (100)6 (100)7 (100)13 (100)6 (100)
 Nausea8 (50)4 (67)12 (55)4 (29)3 (50)4 (57)7 (54)3 (50)
 Anemia4 (25)3 (50)7 (32)10 (71)2 (33)5 (71)7 (54)5 (83)
 Fatigue4 (25)3 (50)7 (32)7 (50)2 (33)4 (57)6 (46)4 (67)
 Vomiting5 (31)2 (33)7 (32)2 (14)1 (17)4 (57)5 (39)2 (33)
 Cough4 (25)3 (50)7 (32)3 (21)1 (17)2 (29)3 (23)2 (33)
 Dyspnea5 (31)1 (17)6 (27)7 (50)2 (33)3 (43)5 (39)3 (50)
 Thrombocytopenia5 (31)2 (33)6 (27)2 (14)2 (33)2 (29)4 (31)2 (33)
 Constipation5 (31)2 (33)7 (32)4 (29)4 (67)4 (57)8 (62)3 (50)
 Headache3 (19)1 (17)4 (18)3 (21)4 (67)1 (14)5 (39)1 (17)
 Alopecia0008 (57)01 (14)1 (8)5 (83)
 Decreased appetite2 (13)02 (9)6 (43)03 (43)3 (23)1 (17)
 Neutropenia1 (6)1 (17)2 (9)6 (43)1 (17)1 (14)2 (15)4 (67)
 Diarrhea0006 (43)2 (33)4 (57)6 (46)4 (67)
 Weight decrease4 (25)1 (17)5 (23)1 (7)1 (17)2 (29)3 (23)3 (50)
Grade ≥3 TEAEs†12 (75)5 (83)17 (77)10 (71)5 (83)7 (100)12 (92)6 (100)
 Thrombocytopenia2 (13)1 (17)3 (14)01 (17)1 (14)2 (15)2 (33)
 Anemia3 (19)03 (14)3 (21)1 (17)2 (29)3 (23)0
 Neutropenia1 (6)1 (17)2 (9)4 (29)01 (14)1 (8)3 (50)
 Pneumonia1 (6)1 (17)2 (9)01 (17)01 (8)0
 ALT increase1 (6)01 (5)2 (14)01 (14)1 (8)0
 AST increase1 (6)01 (5)2 (14)01 (14)1 (8)0
 Asthenia01 (17)1 (5)2 (14)0000
 Fatigue01 (17)1 (5)3 (21)0001 (17)
 Vomiting0001 (7)0000
Dose-limiting toxicity‡2 (13)02 (9)1 (7)1 (17)1 (14)2 (15)0
 AST increase0001 (7)0000
 Vertebral artery dissection00001 (17)01 (7)0
 Hypertension1 (6)01 (5)00000
 Mucosal inflammation1 (6)01 (5)00000
 Neutrophil count decreased§000001 (14)1 (7)0
TEAE leading to treatment discontinuation3 (19)1 (17)4 (18)4 (29)2 (33)1 (14)3 (23)1 (17)
  • *Any-grade TEAEs are listed for AEs that occurred in >25% of patients overall in any part.

  • †Grade ≥3 TEAEs and SAEs are listed for AEs that occurred in ≥2 patients overall in any part.

  • ‡DLTs were grade 3 unless otherwise noted.

  • §Grade 4.

  • AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BEV, bevacizumab; C–P, carboplatin–paclitaxel; DLT, dose-limiting toxicitie ; DOS, dostarlimab; NIR, niraparib; QD, once daily; SAE, serious adverse event; TEAE, treatment-emergent adverse event.