TABLE 3.
All grade and grade 3/4 adverse events (AEs) suspected to be related to study drug treatment in the phase I trial of spartalizumab in Japanese patients with advanced malignancies
| AE, n (%) | 1 mg/kg Q2W n = 6 | 3 mg/kg Q2W n = 6 | 10 mg/kg Q2W n = 6 | All patients N = 18 | ||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
| Total | 5 | 2 | 3 | 0 | 3 | 0 | 11 (61) | 2 (11) |
| Maculopapular rash | 0 | 0 | 2 | 0 | 2 | 0 | 4 (22) | 0 (0) |
| Malaise | 1 | 0 | 0 | 0 | 1 | 0 | 2 (11) | 0 (0) |
| Increased blood alkaline phosphatase | 2 | 1 | 0 | 0 | 0 | 0 | 2 (11) | 1 (6) |
| Hyperthyroidism | 0 | 0 | 0 | 0 | 1 | 0 | 1 (6) | 0 (0) |
| Hypothyroidism | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Dysphagia | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Increased ALT | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Increased AST | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Increased blood creatine phosphokinase | 1 | 1 | 0 | 0 | 0 | 0 | 1 (6) | 1 (6) |
| Decreased blood thyroid‐stimulating hormone | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Increased free thyroxine | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Decreased appetite | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Hyperglycemia | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Hypoalbuminemia | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Hypokalemia | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Hypophosphatemia | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Myalgia | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Myositis | 1 | 0 | 0 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Interstitial lung disease | 0 | 0 | 0 | 0 | 1 | 0 | 1 (6) | 0 (0) |
| Onychomadesis | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
| Pruritus | 0 | 0 | 0 | 0 | 1 | 0 | 1 (6) | 0 (0) |
| Rash | 0 | 0 | 1 | 0 | 0 | 0 | 1 (6) | 0 (0) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; Q2W, once every 2 wk.