AEs reported by ≥5% of patients in any treatment group
| Cindunistat | |||
|---|---|---|---|
| 50 mg/day | 200 mg/day | Placebo | |
| N=482 | N=485 | N=485 | |
| Patients with AEs | 371 (77.0) | 381 (78.6) | 364 (75.1) |
| Discontinued study due to AE | 41 (8.5) | 54 (11.1) | 40 (8.2) |
| Patients with SAEs | 43 (8.9) | 61 (12.6) | 49 (10.1) |
| AEs* occurring in ≥5% of any treatment group | |||
| Arthralgia | 71 (14.7) | 67 (13.8) | 66 (13.6) |
| Hypertension (SMQ*) | 46 (9.5) | 54 (11.1) | 43 (8.9) |
| Back pain | 31 (6.4) | 32 (6.6) | 43 (8.9) |
| Upper respiratory infection | 40 (8.3) | 31 (6.4) | 30 (6.2) |
| Nasopharyngitis | 33 (6.8) | 41 (8.5) | 25 (5.2) |
| Fall | 28 (5.8) | 43 (8.9) | 28 (5.8) |
| Diarrhoea | 22 (4.6) | 27 (5.6) | 29 (6.0) |
| Headache | 32 (6.6) | 27 (5.6) | 18 (3.7) |
| Bronchitis | 25 (5.2) | 30 (6.2) | 20 (4.1) |
| Urinary tract infection | 24 (5.0) | 22 (4.5) | 26 (5.4) |
| Osteoarthritis | 26 (5.4) | 24 (4.9) | 21 (4.3) |
Data are n (%).
*Includes the following terms: blood pressure increased, diastolic hypertension, hypertension, hypertensive crisis and systolic hypertension.
AE, adverse event; SAE, serious adverse events.