Table 1.

Bladder cancer events in the EMPA-REG OUTCOME trial

Events	Placebo	Empagliflozin 10 mg	Empagliflozin 25 mg	Empagliflozin pooled
Events from first intake of study drug up to 7 days after the last intake of study drug	n = 2333	n = 2345	n = 2342	n = 4687
Bladder cancer	3 (0.1)	3 (0.1)	8 (0.3)	11 (0.2)
Bladder cancer	0	1 (< 0.1)	5 (0.2)	6 (0.1)
Bladder cancer recurrent	0	0	1 (< 0.1)	1 (< 0.1)
Bladder cancer transitional cell carcinoma	0	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)
Transitional cell carcinoma	3 (0.1)	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)
Events from first intake of study drug up to trial termination	n = 2333	n = 2345	n = 2342	n = 4687
Bladder cancer	5 (0.2)	3 (0.1)	9 (0.4)	12 (0.3)
Bladder cancer	1 (< 0.1)	1 (< 0.1)	6 (0.3)	7 (0.1)
Bladder cancer recurrent	0	0	1 (< 0.1)	1 (< 0.1)
Bladder cancer transitional cell carcinoma	0	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)
Transitional cell carcinoma	4 (0.1)	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)
Events with onset after 6 months’ cumulative exposure up to trial termination	n = 2187	n = 2216	n = 2190	n = 4406
Bladder cancer	4 (0.2)	3 (0.1)	7 (0.3)	10 (0.2)
Bladder cancer	1 (< 0.1)	1 (< 0.1)	5 (0.2)	6 (0.1)
Bladder cancer recurrent	0	0	0	0
Bladder cancer transitional cell carcinoma	0	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)
Transitional cell carcinoma	3 (0.1)	1 (< 0.1)	1 (< 0.1)	2 (< 0.1)

Data are n (%) with events in patients treated with ≥1 dose of study drug

Bladder cancer events were identified based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (plus medical review of cases for events coded as transitional cell carcinoma)