Table 2 Overview of adverse events
Cohorts | 0·5 mg/kg (N = 3) | 1 mg/kg (N = 3) | 2 mg/kg (N = 3) | 3 mg/kg (N = 3) | 5 mg/kg (N = 5) | Total (N = 17) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
n (%) | M | n (%) | m | n (%) | m | n (%) | m | n (%) | m | n (%) | m | |
Any adverse event | 2 (66·7%) | 2 | 3 (100%) | 7 | 2 (66·7%) | 3 | 3 (100%) | 16 | 5 (100%) | 9 | 15 (88·2%) | 37 |
Any serious adverse event | 1 (33·3%) | 1 | 0 | 0 | 0 | 0 | 1 (33·3%) | 1 | 0 | 0 | 2 (11·8%) | 2 |
Adverse events by severity | ||||||||||||
Grade 0-1 | 0 | 0 | 3 (100%) | 5 | 0 | 0 | 3 (100%) | 8 | 5 (100%) | 9 | 11 (64·7%) | 22 |
Grade 2 | 2 (66·7%) | 2 | 2 (66·7%) | 2 | 2 (66·7%) | 3 | 2 (66·7%) | 8 | 0 | 0 | 8 (47·1%) | 15 |
Grade > = 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse events by causality | ||||||||||||
Suspected | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Unsuspected | 2 (66·7%) | 2 | 3 (100%) | 7 | 2 (66·7%) | 3 | 3 (100%) | 16 | 5 (100%) | 9 | 15 (88·2%) | 37 |