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Table 7 Adverse drug reactions in the safety analysis set
| Adverse drug reactions | Cases | Cases without diabetes drug | Cases with diabetes drug |
|---|---|---|---|
| Number | 5978 | 2382 | 3596 |
| ADRs | 306 (5.1%) | 103 (4.3%) | 203 (5.6%) |
| Blood creatine phosphokinase increased | 48 (0.8%) | 17 (0.7%) | 31 (0.9%) |
| Blood creatinine increased | 46 (0.8%) | 18 (0.8%) | 28 (0.8%) |
| Blood urea increased | 29 (0.5%) | 10 (0.4%) | 19 (0.5%) |
| Renal impairment | 19 (0.3%) | 8 (0.3%) | 11 (0.3%) |
| Aspartate aminotransferase increased | 18 (0.3%) | 7 (0.3%) | 11 (0.3%) |
| Myalgia | 17 (0.3%) | 6 (0.3%) | 11 (0.3%) |
| Hepatic function abnormal | 15 (0.3%) | 2 (0.1%) | 13 (0.4%) |
| Pruritus | 13 (0.2%) | 6 (0.3%) | 7 (0.2%) |
| Alanine aminotransferase increased | 13 (0.2%) | 5 (0.2%) | 8 (0.2%) |
| Rash | 12 (0.2%) | 6 (0.3%) | 6 (0.2%) |
| Dyspepsia | 7 (0.1%) | 1 (0.0%) | 6 (0.2%) |
| Others | 72 (1.2%) | 19 (0.8%) | 53 (1.5%) |
