TABLE 3.

Physician‐reported TRAEs with avelumab

Patients with TRAEs, n (%) a	Treated patients (N = 335)
	Nonserious events	Serious events	Total events
Infusion‐related TRAEs b
Infusion‐related reaction c	7 (2.1)	1 (0.3)	8 (2.4)
Pyrexia	5 (1.5)	2 (0.6)	7 (2.1)
Chills	1 (0.3)	2 (0.6)	3 (0.9)
Asthenia	1 (0.3)	1 (0.3)	2 (0.6)
Tachycardia	0	2 (0.6)	2 (0.6)
Abdominal pain	1 (0.3)	0	1 (0.3)
Anaphylactic reaction	1 (0.3)	0	1 (0.3)
Back pain	1 (0.3)	0	1 (0.3)
Chest pain	1 (0.3)	0	1 (0.3)
Cough	0	1 (0.3)	1 (0.3)
Hypersensitivity	0	1 (0.3)	1 (0.3)
Oxygen saturation decreased	0	1 (0.3)	1 (0.3)
Tremor	0	1 (0.3)	1 (0.3)
Vomiting	1 (0.3)	0	1 (0.3)
Immune‐related TRAEs d
Hypothyroidism	1 (0.3)	1 (0.3)	2 (0.6)
Blood creatine phosphokinase increased	1 (0.3)	0	1 (0.3)
Facial paralysis	0	1 (0.3)	1 (0.3)
Myasthenia gravis	0	1 (0.3)	1 (0.3)
Liver disorder	0	1 (0.3)	1 (0.3)
Myositis	1 (0.3)	0	1 (0.3)
Pneumonitis	0	1 (0.3)	1 (0.3)
Other TRAEs
Dyspnea	0	3 (0.9)	3 (0.9)
Decreased appetite	2 (0.6)	0	2 (0.6)
Rash	2 (0.6)	0	2 (0.6)
Acute myocardial infarction	0	1 (0.3)	1 (0.3)
Alanine aminotransferase increased	1 (0.3)	0	1 (0.3)
Anemia	0	1 (0.3)	1 (0.3)
Arthralgia	1 (0.3)	0	1 (0.3)
Aspartate aminotransferase increased	1 (0.3)	0	1 (0.3)
Autoimmune colitis	0	1 (0.3)	1 (0.3)
Colitis	0	1 (0.3)	1 (0.3)
Eczema	0	1 (0.3)	1 (0.3)
Edema peripheral	0	1 (0.3)	1 (0.3)
Fatigue	1 (0.3)	0	1 (0.3)
Hepatic enzyme increased	1 (0.3)	0	1 (0.3)
Hepatitis	1 (0.3)	0	1 (0.3)
Hyperglycemia	0	1 (0.3)	1 (0.3)
Hyperthyroidism	1 (0.3)	0	1 (0.3)
Metastases to meninges	0	1 (0.3)	1 (0.3)
Nausea	1 (0.3)	0	1 (0.3)
Neutropenia	0	1 (0.3)	1 (0.3)
Pulmonary fibrosis	0	1 (0.3)	1 (0.3)
Rectal abscess	0	1 (0.3)	1 (0.3)
Urinary tract infection	0	1 (0.3)	1 (0.3)
Vertigo	1 (0.3)	0	1 (0.3)

Abbreviation: TRAE, treatment‐related adverse event.

^a The table shows preferred terms for TRAEs obtained from the safety database, including unsolicited cumulative events provided by the treating physician. Overall safety events may have been underreported in this ad hoc program. Serious events refer to adverse events that were considered life‐threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in death, or were otherwise considered medically important.

^b Infusion‐related reaction adverse events based on a prespecified list of Medical Dictionary for Regulatory Activities preferred terms.

^c Based on the single Medical Dictionary for Regulatory Activities preferred term for infusion‐related reaction.

^d Immune‐related adverse event based on medical review.