Table 3

Safety

Parameter, n (%)dMMR/MSI-H EC
(N=129)
MMRp/MSS EC
(N=161)
Overall
(N=290)
Safety summary
Any TEAE123 (95.3)161 (100)284 (97.9)
 Grade≥3 TEAE62 (48.1)90 (55.9)152 (52.4)
Any-grade TRAE82 (63.6)114 (70.8)196 (67.6)
 Grade≥3 TRAE17 (13.2)31 (19.3)48 (16.6)
Treatment-related SAE12 (9.3)13 (8.1)25 (8.6)
Any TRAE leading to discontinuation5 (3.9)11 (6.8)16 (5.5)
TRAE leading to death000
Any-grade TRAEs in >5% of patients
Fatigue17 (13.2)34 (21.1)51 (17.6)
Diarrhea21 (16.3)19 (11.8)40 (13.8)
Nausea16 (12.4)24 (14.9)40 (13.8)
Asthenia18 (14.0)13 (8.1)31 (10.7)
Anemia9 (7.0)18 (11.2)27 (9.3)
Hypothyroidism9 (7.0)16 (9.9)25 (8.6)
Arthralgia11 (8.5)10 (6.2)21 (7.2)
Rash7 (5.4)14 (8.7)21 (7.2)
Vomiting5 (3.9)17 (10.6)21 (7.2)
AST increased4 (3.1)15 (9.3)19 (6.6)
Pruritus11 (8.5)7 (4.3)18 (6.2)
Decreased appetite5 (3.9)13 (8.1)18 (6.2)
ALT increased5 (3.9)13 (8.1)18 (6.2)
Amylase increased5 (3.9)11 (6.8)16 (5.5)
Grade ≥3 TRAEs that occurred in ≥2 (0.5%) patients
Anemia5 (3.9)3 (1.9)8 (2.8)
ALT increased2 (1.6)2 (1.2)4 (1.4)
Diarrhea2 (1.6)2 (1.2)4 (1.4)
Fatigue04 (2.5)4 (1.4)
Lipase increased3 (2.3)1 (0.6)4 (1.4)
Amylase increased1 (0.8)3 (1.9)4 (1.4)
AST increased03 (1.9)3 (1.0)
Hyperglycemia03 (1.9)3 (1.0)
Colitis2 (1.6)02 (0.7)
Constipation1 (0.8)1 (0.6)2 (0.7)
Hypertension1 (0.8)1 (0.6)2 (0.7)
Nausea02 (1.2)2 (0.7)
Pulmonary embolism1 (0.8)1 (0.6)2 (0.7)
Transaminases increased2 (1.6)02 (0.7)
  • ALT, alanine aminotransferase; AST, aspartate transaminase; dMMR, mismatch repair deficient; EC, endometrial cancer; MMR, mismatch repair proficient; MMRp, mismatch repair proficient; MSI-H, microsatellite instability-high; MSS, microsatellite stable; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.