Parameter, n (%) | dMMR/MSI-H EC (N=129) | MMRp/MSS EC (N=161) | Overall (N=290) |
Safety summary | |||
Any TEAE | 123 (95.3) | 161 (100) | 284 (97.9) |
Grade≥3 TEAE | 62 (48.1) | 90 (55.9) | 152 (52.4) |
Any-grade TRAE | 82 (63.6) | 114 (70.8) | 196 (67.6) |
Grade≥3 TRAE | 17 (13.2) | 31 (19.3) | 48 (16.6) |
Treatment-related SAE | 12 (9.3) | 13 (8.1) | 25 (8.6) |
Any TRAE leading to discontinuation | 5 (3.9) | 11 (6.8) | 16 (5.5) |
TRAE leading to death | 0 | 0 | 0 |
Any-grade TRAEs in >5% of patients | |||
Fatigue | 17 (13.2) | 34 (21.1) | 51 (17.6) |
Diarrhea | 21 (16.3) | 19 (11.8) | 40 (13.8) |
Nausea | 16 (12.4) | 24 (14.9) | 40 (13.8) |
Asthenia | 18 (14.0) | 13 (8.1) | 31 (10.7) |
Anemia | 9 (7.0) | 18 (11.2) | 27 (9.3) |
Hypothyroidism | 9 (7.0) | 16 (9.9) | 25 (8.6) |
Arthralgia | 11 (8.5) | 10 (6.2) | 21 (7.2) |
Rash | 7 (5.4) | 14 (8.7) | 21 (7.2) |
Vomiting | 5 (3.9) | 17 (10.6) | 21 (7.2) |
AST increased | 4 (3.1) | 15 (9.3) | 19 (6.6) |
Pruritus | 11 (8.5) | 7 (4.3) | 18 (6.2) |
Decreased appetite | 5 (3.9) | 13 (8.1) | 18 (6.2) |
ALT increased | 5 (3.9) | 13 (8.1) | 18 (6.2) |
Amylase increased | 5 (3.9) | 11 (6.8) | 16 (5.5) |
Grade ≥3 TRAEs that occurred in ≥2 (0.5%) patients | |||
Anemia | 5 (3.9) | 3 (1.9) | 8 (2.8) |
ALT increased | 2 (1.6) | 2 (1.2) | 4 (1.4) |
Diarrhea | 2 (1.6) | 2 (1.2) | 4 (1.4) |
Fatigue | 0 | 4 (2.5) | 4 (1.4) |
Lipase increased | 3 (2.3) | 1 (0.6) | 4 (1.4) |
Amylase increased | 1 (0.8) | 3 (1.9) | 4 (1.4) |
AST increased | 0 | 3 (1.9) | 3 (1.0) |
Hyperglycemia | 0 | 3 (1.9) | 3 (1.0) |
Colitis | 2 (1.6) | 0 | 2 (0.7) |
Constipation | 1 (0.8) | 1 (0.6) | 2 (0.7) |
Hypertension | 1 (0.8) | 1 (0.6) | 2 (0.7) |
Nausea | 0 | 2 (1.2) | 2 (0.7) |
Pulmonary embolism | 1 (0.8) | 1 (0.6) | 2 (0.7) |
Transaminases increased | 2 (1.6) | 0 | 2 (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.