Table 2.
SB102 adverse events considered related to SON-1010.
| Preferred Term (PT) a | 50 ng/kg (N=6) n (%) |
100 ng/kg (N=6) n (%) |
150 ng/kg (N=6) n (%) |
300 ng/kg (N=5) n (%) |
Placebo (N=8) n (%) |
|---|---|---|---|---|---|
| Injection site reaction | 2 (40.0%) | ||||
| Injection site erythema | 1 (16.7%) | 1 (16.7%) | |||
| Injection site pain | 2 (33.3%) | 1 (16.7%) | 1 (12.5%) | ||
| Injection site induration | 1 (16.7%) | 2 (33.3%) | |||
| Pyrexia | 1 (16.7%) | 2 (40.0%) | |||
| Axillary pain | 2 (33.3%) | ||||
| Fatigue | 1 (16.7%) | 1 (12.5%) | |||
| Chills | 1 (16.7%) | ||||
| Malaise | 1 (16.7%) | ||||
| Headache | 1 (16.7%) | 3 (50.0%) | 2 (33.3%) | 2 (40.0%) | |
| Dizziness | 1 (16.7%) | ||||
| Somnolence | 1 (16.7%) | ||||
| Myalgia | 1 (16.7%) | 1 (16.7%) | 1 (20.0%) | ||
| Neck pain | 1 (16.7%) | ||||
| Abdominal pain | 1 (16.7%) | 1 (12.5%) | |||
| Diarrhea | 1 (16.7%) | ||||
| Nausea | 1 (12.5%) | ||||
| Neutropenia | 1 (16.7%) | ||||
| Iron deficiency anemia | 1 (16.7%) | ||||
| Hordeolum | 1 (12.5%) | ||||
| Upper Respiratory Infection | 1 (16.7%) | ||||
| Night sweats | 1 (16.7%) | ||||
| Rash | 1 (16.7%) | ||||
| Transaminases increased | 1 (20.0%) | ||||
| Blepharospasm | 1 (16.7%) | ||||
| Hot flush | 1 (12.5%) | ||||
| Influenza like illness (Grade 2) | 1 (20.0%) | ||||
| Headache (Grade 2) | 1 (16.7%) | 1 (16.7%) | 1 (12.5%) | ||
| Neutropenia (Grade 2) | 1 (16.7%) |
a
All TEAEs considered to be possibly, probably, or definitely related to the injection were grade 1, apart from those noted as grade 2. N = number in group; n = number with event.