Table 5.

AEs and severe or documented hypoglycaemic episodes

	Patients, n (%)	Events, n
All AEs	76 (35.3)	157
Serious AEs	13 (6.0)	20
Severity of AEs
Mild	55 (25.6)	99
Moderate	27 (12.6)	45
Severe	8 (3.7)	13
Serious adverse drug reactions	6 (2.8)	12
AEs leading to treatment discontinuation	22 (10.2)	43
Gastrointestinal AEs	51 (23.7)	83
Severe or documented hypoglycaemia between baseline and EOS	14 (6.5)	29

Data are based on the full analysis set (n = 215), except for the hypoglycaemia data, which are based on the effectiveness analysis set (n = 171)

AE adverse event, EOS end of study