Table 3

AEs reported by ≥5% of patients in any treatment group

Cindunistat
50 mg/day200 mg/dayPlacebo
N=482N=485N=485
Patients with AEs371 (77.0)381 (78.6)364 (75.1)
Discontinued study due to AE41 (8.5)54 (11.1)40 (8.2)
Patients with SAEs43 (8.9)61 (12.6)49 (10.1)
AEs* occurring in ≥5% of any treatment group
 Arthralgia71 (14.7)67 (13.8)66 (13.6)
 Hypertension (SMQ*)46 (9.5)54 (11.1)43 (8.9)
 Back pain31 (6.4)32 (6.6)43 (8.9)
 Upper respiratory infection40 (8.3)31 (6.4)30 (6.2)
 Nasopharyngitis33 (6.8)41 (8.5)25 (5.2)
 Fall28 (5.8)43 (8.9)28 (5.8)
 Diarrhoea22 (4.6)27 (5.6)29 (6.0)
 Headache32 (6.6)27 (5.6)18 (3.7)
 Bronchitis25 (5.2)30 (6.2)20 (4.1)
 Urinary tract infection24 (5.0)22 (4.5)26 (5.4)
 Osteoarthritis26 (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.