Table 3. Adverse events.
| Description | n (%) |
|---|---|
| n | 72 |
| Any AE, n (%) | 64 (88.9) |
| Any TEAEs, n (%) | 56 (77.8) |
| Any SAEs, n (%) | 3 (4.2) |
| Any drug-related AEs, n (%) | 21 (29.2) |
| Drug-related SAEs, n (%) | 1 (1.4) |
| Discontinuation of study drug because of AEs, n (%) | 3 (4.2) |
| Drug-related TEAEs, n (%) | 21 (29.2) |
| Drug-related TEAEs by MeDRA system organ class, n (%) | |
| Cardiac disorders | 7 (9.7) |
| Tachycardia | 5 (6.9) |
| Acute myocardial infarction | 1 (1.4) |
| Ventricular extrasystoles | 1 (1.4) |
| Gastrointestinal disorders | 6 (8.3) |
| Gingival hypertrophy | 3 (4.2) |
| Constipation | 2 (2.8) |
| Diarrhea | 1 (1.4) |
| General disorders and administration site conditions | 3 (4.2) |
| Feeling abnormal | 1 (1.4) |
| Edema | 1 (1.4) |
| Peripheral edema | 1 (1.4) |
| Investigations | 2 (2.8) |
| Elevated gamma-glutamyltransferase | 1 (1.4) |
| Glucose present in urine | 1 (1.4) |
| Metabolism and nutrition disorders | 2 (2.8) |
| Diabetes mellitus | 2 (2.8) |
| Nervous system disorders | 1 (1.4) |
| Dizziness | 1 (1.4) |
| Vascular disorders | 2 (2.8) |
| Orthostatic hypotension | 1 (1.4) |
| Flushing | 1 (1.4) |
Abbreviations: AE, adverse event; MeDRA, Medical Dictionary for Regulatory Activities; SAEs, serious adverse events; TEAEs, treatment-emergent adverse events.