Table 2.
Adverse Events
| CTCAE Term | All Grades: No. (% of Patients) (n = 30) | Grades 3+: No. (% of Patiens) (n = 30) |
|---|---|---|
| Adverse effects that led to temporary or permanent avelumab discontinuation | ||
| Disease progression | 19 (63.3) | 17 (56.7) |
| Radiation necrosis | 2 (6.7) | 2 (6.7) |
| Thromboembolic event | 2 (6.7) | 2 (6.7) |
| Seizure | 2 (6.7) | 2 (6.7) |
| COPD exacerbation | 1 (3.3) | 1 (3.3) |
| Rash NOS | 1 (3.3) | 0 |
| Erythema multiform | 1 (3.3) | 1 (3.3) |
| Platelet count decreased | 1 (3.3) | 1 (3.3) |
| Fever | 1 (3.3) | 0 |
| Hypotension | 1 (3.3) | 0 |
| Urinary tract infection | 2 (6.7) | 2 (6.7) |
| Fatigue | 1 (3.3) | 0 |
| Meningitis | 1 (3.3) | 1 (3.3) |
| AST elevated | 3 (6.7) | 0 |
| GGT elevated | 3 (6.7) | 3 (6.7) |
| LDH elevated | 2 (6.7) | 0 |
| ALT elevated | 1 (3.3) | 1 (3.3) |
| Alkaline phosphatase increased | 1 (3.3) | 0 |
| Localized edema | 1 (3.3) | 1 (3.3) |
| Pneumatosis intestinalis | 1 (3.3) | 1 (3.3) |
| Infusion-related reactions | ||
| Fever | 5 (16.7) | 0 |
| Diarrhea | 2 (6.7) | 0 |
| Nausea | 2 (6.7) | 0 |
| Chills | 1 (3.3) | 0 |
| Headache | 1 (3.3) | 0 |
| Hypertension | 1 (3.3) | 0 |
| Vomiting | 1 (3.3) | 0 |
| Syncope | 1 (3.3) | 1 (3.3) |
| Immune-related adverse events | ||
| Colitis | 2 (6.7) | 0 |
| ALT increased | 3 (6.7) | 1 (3.3) |
| AST increased | 5 (10.0) | 0 |
| LDH increased | 5 (13.3) | 0 |
| GGT increased | 4 (6.7) | 4 (6.7) |
| Alkaline phosphatase increased | 1 (3.3) | 0 |
| Hypophysitis | 2 (6.7) | 0 |
| Hypothyroidism | 2 (6.7) | 1 (3.3) |
| Lipase Increased | 1 (3.3) | 0 |
| Serum amylase increased | 3 (6.7) | 1 (3.3) |
| Mastocytosis | 1 (3.3) | 0 |
| Rash | 1 (3.3) | 0 |