Patients reporting any TEAEs (by system organ class/preferred term), n (%) | |||||
---|---|---|---|---|---|
Placebo (n = 38) | FBX IR 40 mg (n = 37) | FBX XR 40 mg (n = 39) | FBX IR 80 mg (n = 37) | FBX XR 80 mg (n = 38) | |
Cardiac disorders | |||||
Palpitations | 0 | 0 | 2 (5.1) | 0 | 0 |
Gastrointestinal disorders | |||||
Diarrhea | 0 | 2 (5.4) | 0 | 0 | 0 |
Infections and infestations | |||||
Gastroenteritis | 0 | 2 (5.4) | 0 | 0 | 0 |
Urinary tract infection | 0 | 2 (5.4) | 0 | 0 | 0 |
Metabolism and nutrition disorders | |||||
Hyperglycemia | 0 | 0 | 2 (5.1) | 0 | 0 |
Renal and urinary disorders | |||||
Renal failure | 2 (5.3) | 0 | 0 | 0 | 0 |
Vascular disorders | |||||
Hypertension | 1 (2.6) | 1 (2.7) | 0 | 1 (2.7) | 4 (10.5) |