Table 5.
Important identified risks
| Adverse drug reaction | Serious events | All events | ||
|---|---|---|---|---|
| No. of patients | No. of events | No. of patients | No. of eventsa | |
| Important identified risks | ||||
| cuSCC | 1 | 1 | 1 | 1 |
| Other second malignancy | 0 | 0 | 0 | 0 |
| Liver injury | 1 | 1 | 5 | 5 |
| Photosensitivity | 0 | 0 | 5 | 5 |
| QTc prolongation | 0 | 0 | 2 | 2 |
| Skin disorder | 5 | 5 | 17 | 17 |
| Hypersensitivity | 2 | 4 | 10 | 12 |
| Eye disorders | 0 | 0 | 2 | 2 |
| Important potential risks | ||||
| Progression of RAS mutant malignancy | 0 | 0 | 0 | 0 |
| Facial paralysis | 1 | 1 | 1 | 1 |
| Myelosuppression | 1 | 3 | 3 | 5 |
| Gastrointestinal polyps | 0 | 0 | 0 | 0 |
cuSCC cutaneous squamous cell carcinoma
aSerious and non-serious events