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. 2023 Sep 7;55(9):599–609. doi: 10.1055/a-2136-8654

Table 3 Treatment-emergent adverse events of the SS.

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.