Table 2.
Summary of number of patients with AEs
| Empagliflozin 25 mg/linagliptin 5 mg (n = 273) | Empagliflozin 10 mg/linagliptin 5 mg (n = 272) | Empagliflozin 25 mg (n = 276) | Empagliflozin 10 mg (n = 275) | Linagliptin 5 mg (n = 267) | |
|---|---|---|---|---|---|
| One or more AE(s) | 201 (73.6) | 193 (71.0) | 196 (71.0) | 206 (74.9) | 188 (70.4) |
| Most common AEsa | |||||
| Urinary tract infection | 27 (9.9) | 29 (10.7) | 25 (9.1) | 30 (10.9) | 27 (10.1) |
| Headache | 16 (5.9) | 15 (5.5) | 13 (4.7) | 19 (6.9) | 24 (9.0) |
| Upper respiratory tract infection | 19 (7.0) | 19 (7.0) | 18 (6.5) | 13 (4.7) | 16 (6.0) |
| Nasopharyngitis | 18 (6.6) | 16 (5.9) | 10 (3.6) | 16 (5.8) | 20 (7.5) |
| Hyperglycemia | 8 (2.9) | 8 (2.9) | 12 (4.3) | 13 (4.7) | 24 (9.0) |
| Arthralgia | 5 (1.8) | 14 (5.1) | 13 (4.7) | 10 (3.6) | 12 (4.5) |
| One or more drug-relatedb AE(s) | 41 (15.0) | 37 (13.6) | 48 (17.4) | 42 (15.3) | 32 (12.0) |
| One or more AE(s) leading to treatment discontinuation | 12 (4.4) | 10 (3.7) | 9 (3.3) | 16 (5.8) | 6 (2.2) |
| One or more severe AE(s) | 19 (7.0) | 17 (6.3) | 14 (5.1) | 17 (6.2) | 9 (3.4) |
| One or more serious AE(s) | 12 (4.4) | 16 (5.9) | 19 (6.9) | 16 (5.8) | 10 (3.7) |
| Deaths | 0 | 2 (0.7) | 2 (0.7) | 2 (0.7) | 0 |
Data are number of patients (%) with ≥ 1 event in patients treated with ≥ 1 dose of study drug
aPreferred terms reported in ≥ 5% of patients in any treatment group
bAs defined by the investigator