Table 5; online:
Adverse events by body system
| All dose levels N=87* |
Dose 1 (0.125 mg/kg/day) N=11* |
Dose 2 (0.25 mg/kg/day) N=14* |
Dose 3 (0.5 mg/kg/day) N=6* |
Dose 4 (0.75 mg/kg/day) N=56* |
|
|---|---|---|---|---|---|
| Cardiac, (n, %) | 2 (2.3) | - | - | - | Worsening coronary |
| - | - | artery aneurysm | |||
| Dermatologic | 12 (13.8) | Hives/Viral exanthema | Rash, Hair loss, Insect bites | ||
| Gastrointestinal | 5 (5.8) | Constipation | Diarrhea | Emesis | Emesis, elevated AST or ALT |
| Hematologic | 15 (17.2) | Bruising/Epistaxis | Bruising/Epistaxis | - | Bruising/Epistaxis |
| Immunologic | 19 (21.8) | Fever | Fever | Fever | Fever |
| Metabolic | 3 (3.5) | - | Decreased cholesterol | - | Decreased cholesterol |
| Musculoskeletal | 12 (13.4) | Myalgia with transient thigh or foot pain | Myalgia with bilateral leg pain | Arthritis, arthralgia | |
| Neurologic | 7 (8.1) | - | Headache | Headache | Irritability, Headache |
| Ophthalmic | 1 (1.2) | - | - | - | Viral conjunctivitis |
| Oropharyngeal | 2 (2.3) | - | - | - | Otitis media, otalgia |
| Respiratory | 8 (9.2) | Viral illness | Viral illness | Congestion | Viral illness |
| Urologic | 1 (1.2) | - | - | - | Urinary tract infection |
*
N reflects number of adverse events for the dose level