| 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) |