TABLE 5

Summary of TEAEs by intensity and relationship to the study medication (safety population)a

TEAE propertyFINA05FINA10CIPRO10Total
nAE% of patients with AEnAE% of patients with AEnAE% of patients with AEnAE% of patients with AE
Intensity
    Mild5477.12854.94970.013168.6
    Moderate1521.42243.11927.15629.3
    Severe11.412.022.942.1
Relationship to study medication
    Unrelated4970.03772.55375.713972.8
    Related2130.01427.51724.35227.2
  • a Shown is a summary of treatment-emergent adverse events per treatment group and total for the safety population (patients who received at least one administration of the study drug). Displayed are the numbers of adverse events (nAE). Patients received 800 mg finafloxacin q.d. for 5 days (FINA05) or 10 days (FINA10) or 400/500 mg ciprofloxacin for 10 days (CIPRO10).