Treatment-emergent AEs
| Patients, n (%) | Advanced CSCC (group 4, n=63) | |
| Any grade* | Grade ≥3 | |
| Any TEAE | 63 (100) | 34 (54) |
| Any serious TEAE | 34 (54) | 27 (43) |
| TEAEs leading to treatment discontinuation | 11 (18) | 8 (13) |
| TEAEs leading to death | 6 (10) | 6 (10) |
| Most common TEAEs (>10% of patients)† | ||
| Diarrhea | 17 (27) | 1 (2) |
| Pruritus | 16 (25) | 0 (0) |
| Fatigue | 14 (22) | 0 (0) |
| Constipation | 14 (22) | 0 (0) |
| Rash | 12 (19) | 0 (0) |
| Arthralgia | 12 (19) | 0 (0) |
| Anemia | 9 (14) | 3 (5) |
| Maculopapular rash | 8 (13) | 1 (2) |
| Actinic keratosis | 8 (13) | 0 (0) |
| Upper respiratory tract infection | 8 (13) | 0 (0) |
| Dermatitis | 7 (11) | 0 (0) |
| Dyspnea | 7 (11) | 2 (3) |
| Acute kidney injury | 7 (11) | 1 (2) |
| Decreased appetite | 7 (11) | 1 (2) |
| Back pain | 7 (11) | 1 (2) |
| Headache | 7 (11) | 0 (0) |
| Skin infection | 7 (11) | 0 (0) |
| Cough | 7 (11) | 0 (0) |
| Peripheral edema | 7 (11) | 0 (0) |
Data cut-off date: 20 April 2022.
*The severity of TEAEs was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
†TEAEs reported in≥10% of patients ordered by frequency of any-grade events.
AE, adverse event; CSCC, cutaneous squamous cell carcinoma; TEAE, treatment-emergent adverse event.