Table 2.
Incidence of drug adverse reactions of special interest (safety analysis population)
|
System organ class Preferred term |
All n (%) |
Serious n (%) |
|---|---|---|
| Total no. patients | 6,712 | |
| Hypoglycemia | 56 (0.83) | |
| Hypoglycemia | 56 (0.83) | 4 (0.06) |
| Polyuria/pollakiuria | 86 (1.28) | |
| Nocturia | 13 (0.19) | – |
| Pollakiuria | 64 (0.95) | – |
| Polyuria | 6 (0.09) | – |
| Urine output increased | 3 (0.04) | – |
| Volume depletion‐related events | 98 (1.46) | |
| Blood urea increased | 16 (0.24) | – |
| Cerebral infarction | 8 (0.12) | 7 (0.10) |
| Constipation | 25 (0.37) | – |
| Dehydration | 29 (0.43) | 3 (0.04) |
| Depressed level of consciousness | 1 (0.01) | 1 (0.01) |
| Dry mouth | 1 (0.01) | – |
| Hematocrit increased | 5 | (0.07) |
| Hemoconcentration | 1 (0.01) | – |
| Myocardial infarction | 4 (0.06) | 3 (0.04) |
| Polycythemia | 3 (0.04) | – |
| Thirst | 8 (0.12) | – |
| Heat illness | 2 (0.03) | 1 (0.01) |
| Acute kidney injury | 1 (0.01) | 1 (0.01) |
| Urinary tract infection | 79 (1.18) | |
| Bacteriuria | 1 (0.01) | – |
| Cystitis | 40 (0.60) | 1 (0.01) |
| Pyelonephritis | 2 (0.03) | 2 (0.03) |
| Pyelonephritis acute | 3 (0.04) | 3 (0.04) |
| Sepsis | 1 (0.01) | 1 (0.01) |
| Sepsis shock | 2 (0.03) | 2 (0.03) |
| Urethritis | 5 (0.07) | – |
| Urinary tract infection | 26 (0.39) | 2 (0.03) |
| Cystitis‐like symptom | 2 (0.03) | – |
| Cystitis bacterial | 1 (0.01) | – |
| Genital infection | 109 (1.62) | |
| Balanitis candida | 1 (0.01) | – |
| Balanoposthitis | 9 (0.13) | – |
| Genital candidiasis | 3 (0.04) | – |
| Genital herpes | 1 (0.01) | – |
| Penile ulceration | 1 (0.01) | – |
| Prostatitis | 1 (0.01) | – |
| Pruritus genital | 38 (0.57) | – |
| Vaginal infection | 4 (0.06) | – |
| Vulvitis | 4 (0.06) | – |
| Vulvovaginal candidiasis | 18 (0.27) | – |
| Genital infection | 18 (0.27) | – |
| Vulvovaginal pruritus | 5 (0.07) | – |
| Genital infection female | 1 (0.01) | – |
| Vulvar erosion | 5 (0.07) | – |
| Candida infection | 3 (0.04) | – |
| Skin disorders | 52 (0.77) | |
| Alopecia areata | 1 (0.01) | – |
| Cellulitis | 1 (0.01) | 1 (0.01) |
| Dermatitis | 2 (0.03) | – |
| Drug eruption | 1 (0.01) | – |
| Eczema | 8 (0.12) | – |
| Erythema | 1 (0.01) | – |
| Folliculitis | 1 (0.01) | – |
| Herpes zoster | 2 (0.03) | – |
| Palmoplantar keratoderma | 1 (0.01) | – |
| Pruritus | 10 (0.15) | – |
| Rash | 11 (0.16) | – |
| Rash erythematous | 2 (0.03) | – |
| Rash generalized | 2 (0.03) | – |
| Rash pruritic | 2 (0.03) | – |
| Seborrheic dermatitis | 1 (0.01) | – |
| Skin disorder | 1 (0.01) | – |
| Skin erosion | 1 (0.01) | – |
| Skin infection | 1 (0.01) | – |
| Skin ulcer | 1 (0.01) | 1 (0.01) |
| Tinea pedis | 1 (0.01) | – |
| Urticaria | 1 (0.01) | – |
| Pruritus generalized | 2 (0.03) | – |
| Renal disorders | 42 (0.63) | |
| Albumin urine present | 2 (0.03) | – |
| Azotemia | 1 (0.01) | – |
| Blood creatinine increased | 5 (0.07) | – |
| Blood urea increased | 16 (0.24) | – |
| Glomerular filtration rate decreased | 1 (0.01) | 1 (0.01) |
| Proteinuria | 2 (0.03) | – |
| Renal disorder | 2 (0.03) | – |
| Renal failure | 1 (0.01) | – |
| Protein urine present | 3 (0.04) | – |
| Urine albumin/creatinine ratio increased | 1 (0.01) | – |
| Diabetic nephropathy | 2 (0.03) | 1 (0.01) |
| Urinary sediment abnormal | 1 (0.01) | – |
| Renal impairment | 7 (0.10) | 3 (0.04) |
| Acute kidney injury | 1 (0.01) | 1 (0.01) |
| Cardiovascular and cerebrovascular disorders | 51 (0.76) | |
| Acute myocardial infarction | 7 (0.10) | 7 (0.10) |
| Angina pectoris | 2 (0.03) | 1 (0.01) |
| Angina unstable | 1 (0.01) | 1 (0.01) |
| Arrhythmia | 1 (0.01) | – |
| Atrial fibrillation | 3 (0.04) | 1 (0.01) |
| Brain stem infarction | 1 (0.01) | 1 (0.01) |
| Cardiac failure | 2 (0.03) | 1 (0.01) |
| Cardiac failure congestive | 1 (0.01) | 1 (0.01) |
| Cerebral hemorrhage | 2 (0.03) | 2 (0.03) |
| Cerebral infarction | 8 (0.12) | 7 (0.10) |
| Myocardial infarction | 4 (0.06) | 3 (0.04) |
| Palpitations | 3 (0.04) | – |
| Prinzmetal angina | 1 (0.01) | – |
| Subarachnoid hemorrhage | 1 (0.01) | 1 (0.01) |
| Tachycardia | 9 (0.13) | – |
| Transient ischemic attack | 2 (0.03) | – |
| Ventricular extrasystoles | 1 (0.01) | – |
| Lacunar infarction | 3 (0.04) | 3 (0.04) |
Medical Dictionary for Regulatory Activities/Japanese edition version 21.1.