Number of patients with a reported drug-related adverse event divided by dose group (and with patient identification number and number of event occurrence)
| . | 30 U/kg, n = 16 . | Occurrence of event . | 60 U/kg, n = 16 . | Occurrence of event . |
|---|---|---|---|---|
| Abdominal pain | 1 (6.3%) = 42-025 | 3 | 0 (0.0%) | |
| Feeling hot | 1 (6.3%) = 42-025 | 1 | 0 (0.0%) | |
| Hypersensitivity | 1 (6.3%) = 10-003 | 1 | 1 (6.3%) = 10-002 | 1 |
| Arthralgia | 0 (0.0%) | 1 (6.3%) = 42-026 | 1 | |
| Muscle spasms | 1 (6.3%) = 42-025 | 3 | 0 (0.0%) | |
| Dizziness | 1 (6.3%) = 42-025 | 2 | 0 (0.0%) | |
| Headache | 1 (6.3%) = 41-022 | 1 | 1 (6.3%) = 10-029 | 7 |
| Glycosuria | 0 (0.0%) | 1 (6.3%) = 12-024 | 1 | |
| Pruritus | 1 (6.3%) = 42-025 | 1 | 1 (6.3%) = 42-026 | 5 |
| Skin irritation | 0 (0.0%) | 1 (6.3%) = 10-013 | 1 | |
| Total | 3 patients | 12 | 5 patients | 16 |
| . | 30 U/kg, n = 16 . | Occurrence of event . | 60 U/kg, n = 16 . | Occurrence of event . |
|---|---|---|---|---|
| Abdominal pain | 1 (6.3%) = 42-025 | 3 | 0 (0.0%) | |
| Feeling hot | 1 (6.3%) = 42-025 | 1 | 0 (0.0%) | |
| Hypersensitivity | 1 (6.3%) = 10-003 | 1 | 1 (6.3%) = 10-002 | 1 |
| Arthralgia | 0 (0.0%) | 1 (6.3%) = 42-026 | 1 | |
| Muscle spasms | 1 (6.3%) = 42-025 | 3 | 0 (0.0%) | |
| Dizziness | 1 (6.3%) = 42-025 | 2 | 0 (0.0%) | |
| Headache | 1 (6.3%) = 41-022 | 1 | 1 (6.3%) = 10-029 | 7 |
| Glycosuria | 0 (0.0%) | 1 (6.3%) = 12-024 | 1 | |
| Pruritus | 1 (6.3%) = 42-025 | 1 | 1 (6.3%) = 42-026 | 5 |
| Skin irritation | 0 (0.0%) | 1 (6.3%) = 10-013 | 1 | |
| Total | 3 patients | 12 | 5 patients | 16 |