Table 2.

Adverse events occurring during the study (safety analysis set, N = 153)

AEs	n (%)
AEs	107 (69.9)
Drug‐related AEs	35 (22.9)
Serious AEs	11 (7.2)
Serious drug‐related AEs	1 (0.7)
AEs leading to discontinuation	7 (4.6)
Drug‐related AEs leading to discontinuation	3 (2.0)
AEs of special interest
Documented hypoglycaemia	4 (2.6)
Osmotic diuresis	15 (9.8)
Volume depletion	2 (1.3)
Genital infection (males)	1/108 (0.9)
Genital infection (females)	5/45 (11.1)
Urinary tract infection	2 (1.3)
Fracture	3 (2.0)
Blood ketone body increased	3 (2.0)
Hepatic function impairment	2 (1.3)
Skin and subcutaneous tissue disorders	13 (8.5)
Cardiovascular‐related events	3 (2.0)
Malignant neoplasm	2 (1.3)
Gastrointestinal disorders	23 (15.0)