TABLE 4.
Cemiplimab (n = 29) | Chemotherapy (n = 27) | |||
---|---|---|---|---|
Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
Treatment‐emergent AEs, n (%) | 23 (79.3) | 11 (37.9) | 27 (100) | 18 (66.7) |
Occurred in ≥10% of patients in either group, n (%) c | ||||
Pyrexia | 6 (20.7) | 0 | 10 (37.0) | 0 |
Insomnia | 5 (17.2) | 0 | 2 (7.4) | 0 |
Anemia | 4 (13.8) | 4 (13.8) | 11 (40.7) | 7 (25.9) |
Decreased appetite | 4 (13.8) | 1 (3.4) | 7 (25.9) | 2 (7.4) |
Nausea | 4 (13.8) | 0 | 12 (44.4) | 1 (3.7) |
Back pain | 3 (10.3) | 0 | 1 (3.7) | 0 |
Diarrhea | 3 (10.3) | 0 | 6 (22.2) | 2 (7.4) |
Hyperthyroidism | 3 (10.3) | 0 | 0 | 0 |
Hypothyroidism | 3 (10.3) | 0 | 0 | 0 |
Rash | 3 (10.3) | 0 | 1 (3.7) | 0 |
Stomatitis | 3 (10.3) | 0 | 4 (14.8) | 0 |
Hypoalbuminemia | 2 (6.9) | 0 | 3 (11.1) | 2 (7.4) |
Malaise | 2 (6.9) | 0 | 7 (25.9) | 1 (3.7) |
Urinary tract infection | 2 (6.9) | 2 (6.9) | 3 (11.1) | 3 (11.1) |
Vomiting | 2 (6.9) | 0 | 6 (22.2) | 0 |
Constipation | 1 (3.4) | 0 | 5 (18.5) | 0 |
Decreased neutrophil count | 1 (3.4) | 1 (3.4) | 9 (33.3) | 4 (14.8) |
Decreased platelet count | 1 (3.4) | 1 (3.4) | 6 (22.2) | 3 (11.1) |
Decreased white blood cell count | 1 (3.4) | 0 | 5 (18.5) | 4 (14.8) |
Peripheral edema | 1 (3.4) | 0 | 3 (11.1) | 0 |
Fatigue | 0 | 0 | 3 (11.1) | 0 |
Infusion‐related reaction | 0 | 0 | 10 (37.0) | 0 |
Abbreviation: AE, adverse event.
Data cutoff date: January 4, 2021.
Safety was assessed in all randomized patients who received ≥1 dose of the assigned treatment.
The events are listed in descending order of frequency in the cemiplimab treatment group. The events were coded according to the Preferred Terms of the Medical Dictionary for Regulatory Activities, version 23.1. The severity of AEs was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.