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Table 3 Physician-reported TRAEs in patients treated with avelumab in Italy in the MCC EAP

From: Avelumab treatment in Italian patients with metastatic Merkel cell carcinoma: experience from an expanded access program

TRAEs, n (%)a Treated patients (n = 95)
Nonserious events Serious events Total events
Infusion-related TRAEsb
 Infusion-related reactionc 1 (1.1) 2 (2.1) 3 (3.2)
 Pyrexia 1 (1.1) 1 (1.1) 2 (2.1)
 Anaphylactic reaction 0 1 (1.1) 1 (1.1)
Immune-related TRAEsd
 Myasthenia gravis 1 (1.1) 0 1 (1.1)
Other TRAEs
 Anemia 1 (1.1) 0 1 (1.1)
 Urinary tract infection 1 (1.1) 0 1 (1.1)
 Hyperglycemia 1 (1.1) 0 1 (1.1)
  1. AE adverse event, EAP expanded access program, MCC Merkel cell carcinoma, TRAE treatment-related adverse event
  2. aData shown are preferred terms of all TRAEs observed in all patients enrolled from Italy in the EAP extracted from the safety database, including unsolicited cumulative events provided by treating physicians; overall safety events may have been underreported in this ad hoc program
  3. bInfusion-related AEs based on a prespecified list of Medical Dictionary for Regulatory Activities preferred terms
  4. cInfusion-related reaction based on the single Medical Dictionary for Regulatory Activities preferred term
  5. dImmune-related AE based on medical review