Table 2:
1 mg/kg dose (n=4) |
3 mg/kg dose (n=13) |
10 mg/kg dose (n=15) |
20 mg/kg dose (n=21) |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
Fatigue | 0 | 0 | 0 | 5 (39%) | 0 | 0 | 10 (67%) | 1 (7%) | 0 | 5 (24%) | 0 | 0 |
Influenza-like illness | 1 (25%) | 0 | 0 | 1 (8%) | 0 | 0 | 3 (20%) | 0 | 0 | 6 (29%) | 0 | 0 |
Pyrexia | 2 (50%) | 0 | 0 | 2 (15%) | 0 | 0 | 4 (27%) | 0 | 0 | 0 | 0 | 0 |
Chills | 2 (50%) | 0 | 0 | 0 | 0 | 0 | 2 (13%) | 0 | 0 | 2 (10%) | 0 | 0 |
Allergic rhinitis | 0 | 0 | 0 | 2 (15%) | 0 | 0 | 1 (7%) | 0 | 0 | 1 (5%) | 0 | 0 |
Increased blood creatine phosphokinase | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 1 (5%) | 1 (5%) | 1 (5%) |
Diarrhoea | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 2 (13%) | 0 | 0 | 1 (5%) | 0 | 0 |
Infusion-related reaction | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 3 (14%) | 0 | 0 |
Lymphopenia | 0 | 0 | 0 | 2 (15%) | 0 | 0 | 2 (13%) | 0 | 0 | 0 | 0 | 0 |
Decreased lymphocyte count | 0 | 0 | 0 | 2 (15%) | 0 | 0 | 1 (7%) | 1 (7%) | 0 | 0 | 0 | 0 |
Myalgia | 1 (25%) | 0 | 0 | 1 (8%) | 0 | 0 | 0 | 0 | 0 | 2 (10%) | 0 | 0 |
Increased aspartate aminotransferase | 1 (25%) | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 |
Autoimmune disorder | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 1 (7%) | 0 | 1 (5%) | 0 |
Hyperglycaemia | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 2 (13%) | 0 | 0 | 0 | 0 | 0 |
Increased lipase | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (10%) | 1 (5%) | 0 |
Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 2 (13%) | 0 | 0 | 1 (5%) | 0 | 0 |
Rash | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 1 (5%) | 0 | 0 |
Increased alanine aminotransferase | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 |
Increased amylase | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (5%) | 1 (5%) | 0 |
Hypotension | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (10%) | 0 | 0 |
Malaise | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (5%) | 0 | 0 |
Increased blood alkaline phosphatase | 0 | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Lower abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7%) | 0 | 0 | 0 | 0 |
Hypocalcaemia | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Insomnia | 1 (25%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Data are n (%). No grade 5 treatment-related adverse events occurred.