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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