Table 3.

Serious adverse events and adverse events. Values are numbers (percentages)

	Dapagliflozin (n=165)	Placebo (n=163)
Serious adverse events
Urinary tract infection	2 (1.2)	0
Adverse events
Nausea	1 (0.6)	0
Vomiting	1 (0.6)	0
Diarrhoea	1 (0.6)	1 (0.6)
Gastro-oesophageal reflux disease	1 (0.6)	0
Gastrointestinal discomfort	0	2 (1.2)
Dizziness	0	1 (0.6)
Somnolence	0	1 (0.6)
Urinary tract infection	7 (4.2)	3 (1.8)
Vaginitis	2 (1.2)	0
Hypoglycaemia	10 (6.1)	7 (4.3)
Haematuria	1 (0.6)	2 (1.2)
Renal calculi	0	1 (0.6)

Number of participants with at least one treatment related adverse event that occurred during trial. Participants may have had adverse event at more than one time point.