0.23 mg/kg/week (n=59) n (%) | 0.46 mg/kg/week (n=59) n (%) | Total (n=118) n (%) | |
---|---|---|---|
TEAEs | 49 (83.1) | 52 (88.1) | 101 (85.6) |
TRAEs | 14 (23.7) | 20 (33.9) | 34 (28.8) |
SAEs | 5 (8.5) | 7 (11.9) | 12 (10.2) |
Treatment suspension due to TEAEs | 1 (1.7) | 1 (1.7) | 2 (1.7) |
TEAEs occurring in ≥5% of subjects in any group | |||
Upper respiratory tract infection | 32 (54.2) | 31 (52.5) | 63 (53.4) |
Fever | 10 (17.0) | 11 (18.6) | 21 (17.8) |
Cough | 7 (11.9) | 11 (18.6) | 18 (15.3) |
Elevated blood insulin | 8 (13.6) | 10 (17.0) | 18 (15.3) |
Rhinitis | 6 (10.2) | 7 (11.9) | 13 (11.0) |
Rash | 1 (1.7) | 6 (10.2) | 7 (5.9) |
Respiratory infection | 5 (8.5) | 2 (3.4) | 7 (5.9) |
Vomit | 4 (6.8) | 3 (5.1) | 7 (5.9) |
Tonsilitis | 2 (3.4) | 4 (6.8) | 6 (5.1) |
Abdominal pain | 3 (5.1) | 3 (5.1) | 6 (5.1) |
Bronchitis | 1 (1.7) | 4 (6.8) | 5 (4.2) |
Elevated blood glucose | 4 (6.8) | 1 (1.7) | 5 (4.2) |
Head injury | 0 (0.0) | 5 (8.5) | 5 (4.2) |
Pneumonia | 3 (5.1) | 0 (0.0) | 4 (3.4) |
Sneezing | 0 (0.0) | 3 (5.1) | 3 (2.5) |
Indigestion | 3 (5.1) | 0 (0.0) | 3 (2.5) |
SAE: Serious adverse event; SS: Safety set; TEAE: Treatment-emergent adverse event; TRAE: Treatment-related adverse event.