Table 3.
Incidence of ADRs and AEs of special interest
| ADRs and AEs of special interest | Patients (%) | Cases |
|---|---|---|
| ADRs | ||
| Hypoglycaemia-related | 2 (0.24) | 2 |
| Genital infections | 1 (0.12) | 1 |
| Urinary tract infections | 0 | 0 |
| Associated with polyuria or pollakiuria | 2 (0.24) | 2 |
| Associated with volume depletion | 4 (0.49) | 5 |
| Associated with ketone body increased | 0 | 0 |
| Associated with lower limb amputation | 0 | 0 |
| Venous thromboembolism | 0 | 0 |
| Renal disorders | 6 (0.73) | 6 |
| Hepatic disorders | 3 (0.37) | 3 |
| Gastrointestinal disorders | 8 (0.97) | 8 |
| Intestinal obstruction | 0 | 0 |
| Pancreatitis acute | 0 | 0 |
| Skin and subcutaneous tissue disorders | 5 (0.61) | 6 |
| Pemphigoid | 0 | 0 |
| Fracture | 1 (0.12) | 1 |
| ADRs associated with body weight decreased | 1 (0.12) | 1 |
| QT prolongation | 0 | 0 |
| Interstitial pneumonia | 0 | 0 |
| AEs | ||
| Malignant tumours | 4 (0.49) | 4 |
Values are n (%) of patients or number of cases
ADR adverse drug reaction, AE adverse event