A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE)

Table 2 Overall summary of adverse events and adverse events of special interest (safety analysis set)

Adverse events	Dapagliflozin (N = 2990)
Overall summary, No. (%)
≥1 AE	1059 (35.4)
≥1 ADR^a	268 (9.0)
≥1 SAE	186 (6.2)
AE leading to discontinuation	141 (4.7)
AE of special interest, No. (%)
UTI	70 (2.3)
GTI	39 (1.3)
Hypoglycaemia	32 (1.1)
Volume depletion	9 (0.3)
Abnormal blood electrolytes	0
Polyuria	21 (0.7)
Renal impairment	8 (0.3)
Diabetic ketoacidosis	2 (0.1)
Hepatic impairment	7 (0.2)
Haematuria	6 (0.2)

ADR adverse drug reaction, AE adverse event, GTI genital tract infection, SAE serious adverse event, UTI urinary tract infection
^aAEs with a causality assessment designated as ‘yes’ were considered to be ADRs

ISSN: 1741-7015