Physician-reported TRAEs with avelumab in the MCC EAP
| TRAEs* | n=494 | ||
| Non-serious events, n | Serious events, n | Total events, n | |
| Infusion-related reaction | 7 | 2 | 9 |
| Fever | 5 | 2 | 7 |
| Fatigue | 5 | 1 | 6 |
| Rash | 4 | 0 | 4 |
| Asthenia | 3 | 1 | 4 |
| Abdominal pain | 3 | 0 | 3 |
| Chills | 1 | 2 | 3 |
| Dyspnea | 0 | 3 | 3 |
*Data shown are preferred terms of all TRAEs observed in ≥3 patients in the EAP extracted from the safety database, including unsolicited cumulative events provided by treating physicians; overall safety events may have been under-reported in this ad hoc program.
EAP, expanded access program; MCC, Merkel cell carcinoma; TRAE, treatment-related adverse event.