TABLE 4

Summary of AEs occurring in ≥3% of patients per treatment group (safety population)a

AE (preferred term)FINA05FINA10CIPRO10
nAEnS (%)nAEnS (%)nAEnS (%)
Headache76 (7.9)33 (4.0)96 (8.3)
Diarrhea54 (5.3)64 (5.3)55 (6.9)
Nausea55 (6.6)11 (1.3)11 (1.4)
Abdominal pain22 (2.6)11 (1.3)33 (4.2)
Increased blood pressure0054 (5.3)32 (2.8)
Insomnia43 (3.9)22 (2.7)11 (1.4)
Hypokalemia33 (3.9)0022 (2.8)
Superficial thrombophlebitis0011 (1.3)33 (4.2)
Vomiting33 (3.9)0011 (1.4)
Prolonged QT interval on electrocardiogram33 (3.9)0000
Skin reaction000033 (4.2)
  • a Shown are data for patients who received at least one administration of the study drug. Displayed are numbers of adverse events (nAE) and numbers of subjects (nS). Patients received 800 mg finafloxacin q.d. for 5 days (FINA05) or 10 days (FINA10) or 400/500 mg ciprofloxacin for 10 days (CIPRO10).