Empagliflozin

(N = 751)

DPP-4 Inhibitors

(N = 751)

Total

(N = 1502)

Number (%) of patients

with any AE

58 (7.7)

63 (8.4)

121 (8.1)

with any severe AE

2 (0.3)

1 (0.1)

3 (0.2)

with any SAE

6 (0.8)

2 (0.3)

8 (0.5)

with any designated SAE

2 (0.3)

2 (0.3)

4 (0.3)

hospitalised

6 (0.8)

1 (0.1)

7 (0.5)

hospitalised with any AESI

1 (0.1)

1 (0.1)

2 (0.1)

Number (%) of deaths

0

0

0

Number (%) of patients discontinuing study due to AE

0

1 (0.1)

1 (0.1)

Number (%) of patients discontinuing treatment due to AE

1 (0.1)

2 (0.3)

3 (0.2)

In the Index Period during Ramadan

Number (%) of patients with any AE

3 (0.4)

1 (0.1)

4 (0.3)