Adverse event summary in the all-patients-as-treated population
| . | KEYNOTE-170 N = 53 . | |
|---|---|---|
| All . | Grade 3/4∗ . | |
| All treatment-related adverse events | 30 (56.6) | 12 (22.6) |
| Treatment-related AEs in ≥2 patients | ||
| Neutropenia | 10 (18.9) | 7 (13.2) |
| Asthenia | 5 (9.4) | 1 (1.9) |
| Hypothyroidism | 4 (7.5) | 0 |
| Fatigue | 3 (5.7) | 0 |
| Pyrexia | 3 (5.7) | 0 |
| Arthralgia | 2 (3.8) | 0 |
| Aspartate aminotransferase increased | 2 (3.8) | 1 (1.9) |
| Hyperthyroidism | 2 (3.8) | 0 |
| Leukopenia | 2 (3.8) | 0 |
| Myalgia | 2 (3.8) | 0 |
| Vulvovaginal mycotic infection | 2 (3.8) | 0 |
| White blood cell count decreased | 2 (3.8) | 0 |
| . | KEYNOTE-170 N = 53 . | |
|---|---|---|
| All . | Grade 3/4∗ . | |
| All treatment-related adverse events | 30 (56.6) | 12 (22.6) |
| Treatment-related AEs in ≥2 patients | ||
| Neutropenia | 10 (18.9) | 7 (13.2) |
| Asthenia | 5 (9.4) | 1 (1.9) |
| Hypothyroidism | 4 (7.5) | 0 |
| Fatigue | 3 (5.7) | 0 |
| Pyrexia | 3 (5.7) | 0 |
| Arthralgia | 2 (3.8) | 0 |
| Aspartate aminotransferase increased | 2 (3.8) | 1 (1.9) |
| Hyperthyroidism | 2 (3.8) | 0 |
| Leukopenia | 2 (3.8) | 0 |
| Myalgia | 2 (3.8) | 0 |
| Vulvovaginal mycotic infection | 2 (3.8) | 0 |
| White blood cell count decreased | 2 (3.8) | 0 |
Data are presented as number (percentage).
Other treatment-related grade 3/4 AEs experienced by 1 patient (1.9%) each included febrile neutropenia, Clostridioides difficile infection, pneumonia, increased alanine aminotransferase, hepatic enzyme increased, tumor flare, and venous thrombosis.