Table 2.
Overall summary of the incidences of adverse drug reactions (safety analysis population)
| Incidence of ADRs‡ | ||
|---|---|---|
| Non‐serious and serious | Serious | |
| Total no. patients | 6,712 | |
| Total no. patients with ADRs | 345 | 30 |
| Incidence rate of ADRs | 5.14% | 0.45% |
| SOC | ||
|---|---|---|
| PT | Incidence of ADRs, n (%) | |
| Infections and infestations | 78 (1.16) | 6 (0.09) |
| Cystitis† | 21 (0.31) | 1 (0.01) |
| Pneumonia | 1 (0.01) | 1 (0.01) |
| Pyelonephritis acute† | 1 (0.01) | 1 (0.01) |
| Sepsis† | 1 (0.01) | 1 (0.01) |
| Septic shock† | 1 (0.01) | 1 (0.01) |
| Urinary tract infection† | 14 (0.21) | 3 (0.04) |
| Vulvovaginal candidiasis† | 9 (0.13) | – |
| Genital infection† | 12 (0.18) | – |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.01) | 1 (0.01) |
| Pancreatic carcinoma | 1 (0.01) | 1 (0.01) |
| Immune system disorders | 3 (0.04) | 1 (0.01) |
| Anaphylactic shock | 1 (0.01) | 1 (0.01) |
| Metabolism and nutrition disorders | 45 (0.67) | 4 (0.06) |
| Dehydration† | 16 (0.24) | 2 (0.03) |
| Hypoglycemia† | 25 (0.37) | 2 (0.03) |
| Psychiatric disorders | 3 (0.04) | 1 (0.01) |
| Insomnia | 1 (0.01) | 1 (0.01) |
| Nervous system disorders | 23 (0.34) | 4 (0.06) |
| Brain stem infarction | 1 (0.01) | 1 (0.01) |
| Cerebral hemorrhage | 1 (0.01) | 1 (0.01) |
| Depressed level of consciousness† | 1 (0.01) | 1 (0.01) |
| Dizziness | 9 (0.13) | – |
| Lacunar infarction | 1 (0.01) | 1 (0.01) |
| Cardiac disorders | 16 (0.24) | 7 (0.10) |
| Acute myocardial infarction | 3 (0.04) | 3 (0.04) |
| Angina pectoris | 1 (0.01) | 1 (0.01) |
| Cardiac failure | 2 (0.03) | 1 (0.01) |
| Cardiac failure congestive | 1 (0.01) | 1 (0.01) |
| Myocardial infarction† | 1 (0.01) | 1 (0.01) |
| Gastrointestinal disorders | 25 (0.37) | 2 (0.03) |
| Melaena | 2 (0.03) | 1 (0.01) |
| Pancreatitis chronic | 1 (0.01) | 1 (0.01) |
| Hepatobiliary disorders | 12 (0.18) | 2 (0.03) |
| Chronic hepatitis | 1 (0.01) | 1 (0.01) |
| Hepatic function abnormal | 8 (0.12) | 1 (0.01) |
| Skin and subcutaneous tissue disorders | 34 (0.51) | 1 (0.01) |
| Rash† | 9 (0.13) | – |
| Skin ulcer† | 1 (0.01) | 1 (0.01) |
| Renal and urinary disorders | 63 (0.94) | 3 (0.04) |
| Nocturia† | 7 (0.10) | – |
| Pollakiuria† | 38 (0.57) | – |
| Urinary retention | 1 (0.01) | 1 (0.01) |
| Renal impairment | 3 (0.04) | 1 (0.01) |
| Acute kidney injury† | 1 (0.01) | 1 (0.01) |
| Reproductive system and breast disorders | 26 (0.39) | – |
| Pruritus genital† | 16 (0.24) | – |
| Congenital, familial and genetic disorders | 1 (0.01) | 1 (0.01) |
| Phimosis | 1 (0.01) | 1 (0.01) |
| General disorders and administration site conditions | 19 (0.28) | – |
| Malaise | 7 (0.10) | – |
| Investigations | 32 (0.48) | 1 (0.01) |
| Blood potassium decreased | 1 (0.01) | 1 (0.01) |
| Urine ketone body present | 7 (0.10) | – |
Individual adverse drug reactions (ADRs) were coded according to Medical Dictionary for Regulatory Activities version 20.0 and classified according to System Organ Class (SOC) and Preferred Term (PT). †ADRs of special interest. ‡Seven or more patients (≥0.1%) or one or more patients with serious ADR.