TABLE 4.
Adverse events (AEs) of special interest 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 |
|---|---|---|---|---|
| Any AE of special interest | 5 (83) | 3 (50) | 3 (50) | 11 (61) |
| Colitis | ||||
| Diarrhea | 1 (17) | 1 (17) | 1 (17) | 3 (17) |
| Endocrinopathies | ||||
| Decreased blood thyroid‐stimulating hormone | 0 (0) | 1 (17) | 0 (0) | 1 (6) |
| Hyperglycemia | 0 (0) | 1 (17) a | 0 (0) | 1 (6) |
| Hyperthyroidism | 0 (0) | 0 (0) | 1 (17) | 1 (6) |
| Hypothyroidism | 1 (17) | 0 (0) | 0 (0) | 1 (6) |
| Increased free thyroxine | 0 (0) | 1 (17) | 0 (0) | 1 (6) |
| Liver enzyme increases | ||||
| Increased AST | 2 (33) | 0 (0) | 1 (17) | 3 (17) |
| Increased blood alkaline phosphatase | 2 (33) a | 0 (0) | 1 (17) | 3 (17) |
| Increased ALT | 1 (17) | 0 (0) | 1 (17) | 2 (11) |
| Increased blood bilirubin | 1 (17) | 0 (0) | 0 (0) | 1 (6) |
| Nephritis | ||||
| Increased blood creatine | 0 (0) | 0 (0) | 1 (17) | 1 (6) |
| Other immune‐related events: muscular disorder | ||||
| Myositis | 1 (17) | 0 (0) | 0 (0) | 1 (6) |
| Pneumonitis | ||||
| Interstitial lung disease | 0 (0) | 0 (0) | 1 (17) | 1 (6) |
| Rash | ||||
| Maculopapular rash | 0 (0) | 2 (33) | 2 (33) | 4 (22) |
| Pruritus | 2 (33) | 0 (0) | 1 (17) | 3 (17) |
| Rash | 0 (0) | 1 (17) | 0 (0) | 1 (6) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; Q2W, once every 2 wk.
a
Grade 3/4 AEs; all other AEs are grade 1/2.