Table 2.
Treatment-Related Adverse Events Possibly, Probably, or Definitely Attributed to Avelumab
| Events | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total |
|---|---|---|---|---|---|---|
| Allergic infusion reaction | 0 | 5 | 1 | 0 | 0 | 6 |
| Anorexia or weight loss | 3 | 2 | 1 | 0 | 0 | 6 |
| Fatigue | 4 | 2 | 0 | 0 | 0 | 6 |
| Diarrhea | 2 | 1 | 0 | 0 | 0 | 3 |
| Myalgia or arthralgiaa | 1 | 1 | 1 | 0 | 0 | 3 |
| Hypothyroidisma | 1 | 2 | 0 | 0 | 0 | 3 |
| Hyperthyroidisma | 2 | 0 | 0 | 0 | 0 | 2 |
| Noncardiac chest pain | 1 | 0 | 1 | 0 | 0 | 2 |
| Dyspnea | 1 | 1 | 0 | 0 | 0 | 2 |
| Mucositis | 1 | 1 | 0 | 0 | 0 | 2 |
| Pruritus/rash | 2 | 0 | 0 | 0 | 0 | 2 |
| Fever/chills | 2 | 0 | 0 | 0 | 0 | 2 |
| Blood bilirubin increased | 0 | 1 | 0 | 0 | 0 | 1 |
| Dehydration | 0 | 1 | 0 | 0 | 0 | 1 |
| Palmar-plantar erythrodysesthesia syndrome | 1 | 0 | 0 | 0 | 0 | 1 |
| Dysgeusia | 1 | 0 | 0 | 0 | 0 | 1 |
| Headache | 1 | 0 | 0 | 0 | 0 | 1 |
| Eye redness or scleral erythema | 1 | 0 | 0 | 0 | 0 | 1 |
| Gastroesophageal reflux | 1 | 0 | 0 | 0 | 0 | 1 |
| Vomiting | 1 | 0 | 0 | 0 | 0 | 1 |
| Cough | 1 | 0 | 0 | 0 | 0 | 1 |
Note: Toxicities were graded using the CTCAE, version 4.0.
CTCAE, Common Terminology Criteria for Adverse Events.
a
Immune-related adverse event.