Table 3 TEAEs regardless of attribution
Cemiplimab + chemotherapy (n = 312) | Placebo + chemotherapy (n = 153) | |||
|---|---|---|---|---|
Event, n (%) | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 |
Any | 299 (95.8) | 136 (43.6) | 144 (94.1) | 48 (31.4) |
Led to discontinuation | 16 (5.1) | 13 (4.2) | 4 (2.6) | 4 (2.6) |
Led to death | 19 (6.1) | 19 (6.1) | 12 (7.8) | 12 (7.8) |
Events that occurred in ≥10% of patients in either groupa | ||||
Anemia | 136 (43.6) | 31 (9.9) | 61 (39.9) | 10 (6.5) |
Alopecia | 115 (36.9) | 0 | 66 (43.1) | 0 |
Nausea | 78 (25.0) | 0 | 25 (16.3) | 0 |
Hyperglycemia | 55 (17.6) | 6 (1.9) | 18 (11.8) | 0 |
Decreased appetite | 53 (17.0) | 3 (1.0) | 18 (11.8) | 0 |
Alanine aminotransferase increased | 51 (16.3) | 7 (2.2) | 22 (14.4) | 3 (2.0) |
Arthralgia | 48 (15.4) | 2 (0.6) | 20 (13.1) | 0 |
Neutropenia | 48 (15.4) | 18 (5.8) | 19 (12.4) | 9 (5.9) |
Aspartate aminotransferase increased | 46 (14.7) | 1 (0.3) | 18 (11.8) | 3 (2.0) |
Constipation | 43 (13.8) | 1 (0.3) | 17 (11.1) | 0 |
Thrombocytopenia | 41 (13.1) | 8 (2.6) | 19 (12.4) | 2 (1.3) |
Dyspnea | 39 (12.5) | 7 (2.2) | 10 (6.5) | 1 (0.7) |
Asthenia | 38 (12.2) | 6 (1.9) | 18 (11.8) | 2 (1.3) |
Fatigue | 38 (12.2) | 7 (2.2) | 11 (7.2) | 1 (0.7) |
Vomiting | 38 (12.2) | 0 | 15 (9.8) | 0 |
Weight decreased | 35 (11.2) | 4 (1.3) | 13 (8.5) | 0 |
Insomnia | 34 (10.9) | 0 | 11 (7.2) | 0 |
Diarrhea | 33 (10.6) | 4 (1.3) | 10 (6.5) | 0 |
Hypoalbuminemia | 32 (10.3) | 2 (0.6) | 9 (5.9) | 0 |
