Table 2.

Summary of adverse events.

Number of patients, %	Placebo + ACE inhibitor/ARB n = 189	Dapagliflozin 10 mg + ACE inhibitor/ARB n = 167
Overall safety summary
≥1 AE	87 (46.0)	81 (48.5)
AE leading to study drug discontinuation*	2 (1.1)	2 (1.2)
≥1 serious AE	0	6 (3.6)
Serious AE leading to study drug discontinuation*	0	0
≥1 episode of hypoglycaemia	5 (2.6)	10 (6.0)
Hypoglycaemia leading to study drug discontinuation*	0	0
AEs of special interest
Renal events	3 (1.6)	5 (3.0)
Blood creatinine increased	1 (0.5)	4 (2.4)
GFR decreased	1 (0.5)	1 (0.6)
Renal impairment	1 (0.5)	0
Volume reduction events	0	2 (1.2)
Hypovolaemia	0	1 (0.6)
Orthostatic hypotension	0	1 (0.6)
Infections
Urinary tract infection	3 (1.6)	6 (3.6)
Genital infection	5 (2.6)	5 (3.0)
Marked laboratory abnormalities
Serum potassium ≥6 mmol/l	4 (2.2)	4 (2.4)
Serum creatinine ≥1.5× baseline value	2 (1.1)	2 (1.2)

ACE, angiotensin‐converting enzyme; AE, adverse event; ARB, angiotensin receptor blocker.

^*Only hypoglycaemia reported as a serious AE was included as an AE, serious AE, or AE leading to discontinuation.