Table 2.
AEs of special interest occurring within 6 months and 1 year after randomization
| <6 months | <1 year | |||||||
|---|---|---|---|---|---|---|---|---|
| Patients with heart failure at baseline | Patients without heart failure at baseline | Patients with heart failure at baseline | Patients without heart failure at baseline | |||||
| Placebo (N = 244) | Empagliflozin (N = 462) | Placebo (N = 2089) | Empagliflozin (N = 4225) | Placebo (N = 244) | Empagliflozin (N = 462) | Placebo (N = 2089) | Empagliflozin (N = 4225) | |
| Any AE, n (%) | 176 (72.1) | 296 (64.1) | 1400 (67.0) | 2700 (63.9) | 206 (84.4) | 363 (78.6) | 1694 (81.1) | 3246 (76.8) |
| Any serious AE, n (%) | 51 (20.9) | 53 (11.5) | 268 (12.8) | 427 (10.1) | 79 (32.4) | 105 (22.7) | 447 (21.4) | 764 (18.1) |
| Hypoglycaemia a , n (%) | 33 (13.5) | 60 (13.0) | 301 (14.4) | 725 (17.2) | 50 (20.5) | 76 (16.5) | 388 (18.6) | 915 (21.7) |
| Hypoglycaemia requiring assistance (%) | 0 (0) | 1 (0.2) | 8 (0.4) | 17 (0.4) | 0 (0) | 3 (0.6) | 13 (0.6) | 27 (0.6) |
| Acute kidney injury b , n (%) | 1 (0.4) | 1 (0.2) | 5 (0.2) | 6 (0.1) | 1 (0.4) | 2 (0.4) | 7 (0.3) | 12 (0.3) |
| Hyperkalaemia c , n (%) | 1 (0.4) | 3 (0.6) | 11 (0.5) | 13 (0.3) | 3 (1.2) | 4 (0.9) | 23 (1.1) | 23 (0.5) |
| Volume depletion d , n (%) | 3 (1.2) | 11 (2.4) | 32 (1.5) | 73 (1.7) | 10 (4.1) | 20 (4.3) | 47 (2.2) | 111 (2.6) |
| Hypotension e , n (%) | 3 (1.2) | 8 (1.7) | 28 (1.3) | 51 (1.2) | 7 (2.9) | 14 (3.0) | 37 (1.8) | 77 (1.8) |
AEs, adverse events.
The Medical Dictionary for Regulatory Activities Version 18.0 was used to classify AEs by preferred terms.
Hypoglycaemia defined as any hypoglycaemic event that had a glucose value ≤70 mg/dL or where assistance was required.
Based on reported AEs of the preferred term in the Medical Dictionary for Regulatory Activities ‘acute kidney injury’.
Based on the Medical Dictionary for Regulatory Activities preferred terms ‘hyperkalaemia’ and ‘blood potassium increased’.
Based on eight Medical Dictionary for Regulatory Activities preferred terms ‘blood pressure (BP) ambulatory decreased’, ‘BP decreased’, ‘BP systolic decreased’, ‘dehydration’, ‘hypotension’, ‘hypovolaemia’, ‘orthostatic hypotension’, and ‘syncope’.
Based on 10 Medical Dictionary for Regulatory Activities preferred terms ‘blood pressure (BP) ambulatory decreased’, ‘BP decreased’, ‘BP systolic decreased’, ‘BP diastolic decreased’, ‘BP orthostatic decreased’, ‘diastolic hypotension’, ‘hypotension’, ‘mean arterial pressure decreased’, ‘orthostatic hypotension’, and ‘orthostatic intolerance’.