Table 3.
Adverse event summary by disease cohort and by severity
| Event | Cervical (n = 18) | Endometrial (n = 25) | All (n = 43) | |||
|---|---|---|---|---|---|---|
| Any G | G ≥ 3 | Any G | G ≥ 3 | Any G | G ≥ 3 | |
| Serious TEAE | 15 (83.3) | 15 (60.0) | 30 (69.8) | |||
| Any TRAE | 16 (88.9) | 10 (55.6) | 20 (80.0) | 9 (36.0) | 36 (83.7) | 19 (44.2) |
| Serious TRAE | 9 (50.0) | 10 (40.0) | 19 (44.2) | |||
| TRAE leading to discontinuation of any treatment component | 3 (16.7) | 2 (11.1) | 3 (12.0) | 1 (4.0) | 6 (14.0) | 3 (7.0) |
| TRAE leading to delay, interruption, or modification of any treatment component | 10 (55.6) | 6 (33.3) | 16 (64.0) | 6 (24.0) | 26 (60.5) | 12 (27.9) |
| TRAE leading to discontinuation of pembrolizumab | 1 (5.6) | 1 (5.6) | 1 (4.0) | 0 | 2 (4.7) | 1 (2.3) |
| TRAE leading to delay or interruption of pembrolizumab | 8 (44.4) | 5 (27.8) | 13 (52.0) | 6 (24.0) | 21 (48.8) | 11 (25.6) |
| TRAE leading to death | 1 (5.6) | 1 (5.6) | 0 | 0 | 1 (2.3) | 1 (2.3) |
| TRAE occurring in > 15% of patients in either cohort | ||||||
| Clinical | ||||||
| Diarrhea | 6 (33.3) | 1 (5.6) | 11 (44.0) | 3 (12.0) | 17 (39.5) | 4 (9.3) |
| Fatigue | 7 (38.9) | 1 (5.6) | 8 (32.0) | 0 | 15 (34.9) | 1 (2.3) |
| Colitis | 3 (16.7) | 3 (16.7) | 8 (32.0) | 3 (12.0) | 11 (25.6) | 6 (14.0) |
| Anorexia | 2 (11.1) | 0 | 6 (24.0) | 0 | 8 (18.6) | 0 |
| Nausea | 2 (11.1) | 0 | 6 (24.0) | 0 | 8 (18.6) | 0 |
| Vomiting | 2 (11.1) | 0 | 3 (12.0) | 1 (4.0) | 5 (11.6) | 1 (2.3) |
| Constipation | 3 (16.7) | 0 | 4 (16.0) | 0 | 7 (16.3) | 0 |
| Rash, maculo-papular | 3 (16.7) | 1 (5.6) | 0 | 0 | 3 (7.0) | 1 (2.3) |
| Laboratory | ||||||
| Anemia | 5 (27.8) | 3 (16.7) | 5 (20.0) | 1 (4.0) | 10 (23.3) | 4 (9.3) |
| Lymphopenia | 4 (22.2) | 3 (16.7) | 4 (16.0) | 3 (12.0) | 8 (18.6) | 6 (14.0) |
Data are number of patients (%) with at least one event. Definitions are outlined in the supplementary material
TEAE treatment-emergent adverse event, TRAE treatment-related adverse event