Table 2.
Adverse events (safety set)
| Vildagliptin 50 mg qd, n (%) | Placebo, n (%) | |
|---|---|---|
| n | 50 | 55 |
| AEs | 29 (58.0) | 40 (72.7) |
| SAEs | 7 (14.0) | 9 (16.4) |
| Discontinuation due to AEs | 2 (4.0) | 5 (9.1) |
| Deaths | 0 (0.0) | 3 (5.5) |
| AEs in SOCs | ||
| Cardiac disorders | 2 (4.0) | 10 (18.2) |
| Gastrointestinal disorders | 4 (8.0) | 11 (20.0) |
| Infections and infestations | 14 (28.0) | 11 (20.0) |
| Musculoskeletal and connective tissue disorders | 8 (16.0) | 9 (16.4) |
| Nervous system disorders | 9 (18.0) | 15 (27.3) |
| Skin and subcutaneous tissue disorders | 5 (10.0) | 8 (14.5) |
| Most common AEs by preferred terma | ||
| Edema | 6 (12.0) | 9 (16.4) |
| Nasopharyngitis | 6 (12.0) | 4 (7.3) |
| Dizziness | 2 (4.0) | 8 (14.5) |
| Fatigue | 3 (6.0) | 3 (5.5) |
| Hyperhidrosis | 1 (2.0) | 5 (9.1) |
AE adverse event, n number of patients with an AE, SAE serious adverse event, SOC system organ class
a≥10% in the study