Table 3.

Treatment‐emergent adverse events (safety analysis set; data regardless of rescue therapy)

Adverse event category	Number (%) of patients
	DAPA + MET (n = 313)	DAPA + SAXA + MET (n = 312)	GLIM + MET (n = 312)
At least 1 AE	188 (60.1)	158 (50.6)	170 (54.5)
AE leading to discontinuation of study medication	27 (8.6)	12 (3.8)	13 (4.2)
Hospitalization for heart failure	0	0	1 (0.3)
AEs of special interest
UTIs	24 (7.7)	13 (4.2)	12 (3.8)
Genital infections	25 (8.0)	15 (4.8)	2 (0.6)
Hypoglycaemia, number of events (proportion of total events in each category, %)a prior to rescue
Overall events N = 358	10 (2.8)	19 (5.3)	329 (91.9)
Major hypoglycaemiab N = 0	0	0	0
Episode of hypoglycaemiac N = 224	1 (0.4)	7 (3.1)	216 (96.4)
Other episode of hypoglycaemiad N = 65	7 (10.8)	10 (15.4)	48 (73.8)
Confirmed hypoglycaemiae N = 26	0	1 (3.8)	25 (96.2)
Asymptomatic hypoglycaemiaf N = 69	2 (2.9)	2 (2.9)	65 (94.2)

Abbreviations: AE, adverse event; DAPA, dapagliflozin; GLIM, glimepiride; MET, metformin; SAE, serious adverse event; SAXA, saxagliptin; UTI, urinary tract infection.

^aPercentages reflect total number of each type of event across all treatment groups.

^bMajor hypoglycaemic episode: symptomatic episode requiring external assistance with glucose <3.0 mmol/L (<54 mg/dL).

^cHypoglycaemia: symptomatic episode with glucose ≤3.9 mmol/L (≤70 mg/dL).

^dOther episode of hypoglycaemia: symptomatic episode, with or without glucose >3.9 mmol/L (>70 mg/dL).

^eConfirmed hypoglycaemia: typical symptoms with glucose ≤2.8 mmol/L (≤50 mg/dL).

^fAsymptomatic hypoglycaemia: event with absence of symptoms but with glucose ≤3.9 mmol/L (≤70 mg/dL).