Table 2.
Incidence of adverse drug reactions and serious adverse drug reactions
| ADRs [n (%)] | Incidence (N = 2235 patients) |
|---|---|
| Any ADRs | 240 (10.7) |
| ADRs occurring in ≥ 5 patients | |
| Diabetes mellitus | 35 (1.6) |
| Constipation | 21 (0.9) |
| Diabetes mellitus inadequate control | 13 (0.6) |
| Hypertension | 13 (0.6) |
| Hyperuricemia | 11 (0.5) |
| Hepatic function abnormal | 11 (0.5) |
| Dizziness | 9 (0.4) |
| Decreased appetite | 6 (0.3) |
| Weight increased | 6 (0.3) |
| Gastroesophageal reflux disease | 5 (0.2) |
| ADRs leading to discontinuation | 74 (3.3) |
| Serious ADRs | 35 (1.6) |
| Serious ADRs occurring in ≥ 2 patients | |
| Cerebral infarction | 4 (0.2) |
| Myocardial infarction | 3 (0.1) |
| Pancreatic carcinoma | 3 (0.1) |
| Death | 3 (0.1) |
| Sudden death | 2 (0.1) |
| Fall | 2 (0.1) |
ADR Adverse drug reaction