Table 2.
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 |