Table 2.
Adverse events | Single agent OH2 (n=40) |
OH2 with HX008 (n=14) |
||||
Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | |
Fever | 10 | 7 | 1 | 1 | 3 | 0 |
Leukopenia | 3 | 0 | 0 | 0 | 0 | 0 |
Neutropenia | 2 | 0 | 0 | 0 | 0 | 0 |
Thrombocytopenia | 1 | 0 | 0 | 0 | 0 | 0 |
Anemia | 3 | 2 | 0 | 0 | 0 | 0 |
Hyperbilirubinemia | 1 | 1 | 0 | 0 | 1 | 0 |
ALT increased | 2 | 0 | 0 | 0 | 0 | 0 |
AST increased | 2 | 0 | 0 | 0 | 0 | 0 |
QTc prolongation | 0 | 1 | 0 | 0 | 0 | 0 |
Pruritus | 1 | 0 | 0 | 0 | 0 | 0 |
Rash | 2 | 0 | 0 | 0 | 1 | 0 |
Complications of injection | 0 | 3 | 0 | 0 | 0 | 0 |
Abdominal pain | 0 | 2 | 0 | 0 | 0 | 0 |
Diarrhea | 1 | 0 | 0 | 1 | 0 | 0 |
Nausea | 0 | 1 | 0 | 0 | 0 | 0 |
Fatigue | 1 | 0 | 0 | 3 | 0 | 0 |
Myalgia | 1 | 0 | 0 | 0 | 0 | 0 |
Arthralgia | 1 | 0 | 0 | 0 | 0 | 0 |
Proteinuria | 0 | 0 | 0 | 1 | 0 | 0 |
Hypothyroidism | 0 | 0 | 0 | 0 | 1 | 0 |
No grade 4 or 5 treatment-related adverse events occurred in the study.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.