TABLE 5.

Therapy-Related Adverse Events: ITT Group

Adverse EventCiprofloxacin/Dexamethasone (N = 297)Ofloxacin F(N = 302)
Otic events
 Pain ear7 (2.4%)9 (3.0%)
 Discomfort ear*10 (3.4%)3 (1.0%)
 Precipitate ear2 (0.7%)3 (1.0%)
 Tympanostomy tube blockage1 (0.3%)0 (0.0%)
 Tinnitus1 (0.3%)0 (0.0%)
 Infection super ear0 (0.0%)2 (0.7%)
 Irritation ear0 (0.0%)2 (0.7%)
 Pruritus ear0 (0.0%)2 (0.7%)
 Ear debris0 (0.0%)1 (0.3%)
 Edema eardrum0 (0.0%)1 (0.3%)
 Hyperemia eardrum0 (0.0%)1 (0.3%)
Nonotic events
 Headache0 (0.0%)1 (0.3%)
 Monilia oral1 (0.3%)1 (0.3%)
 Diarrhea0 (0.0%)1 (0.3%)
 Irritability2 (0.7%)0 (0.0%)
 Dizziness1 (0.3%)0 (0.0%)
 Crying0 (0.0%)1 (0.3%)
 Cough0 (0.0%)1 (0.3%)
 Erythema1 (0.3%)0 (0.0%)
 Taste perversion1 (0.3%)3 (1.0%)
  • * One patient receiving ciprofloxacin/dexamethasone and 1 patient receiving ofloxacin discontinued from the study as a result of a therapy-related event.

  • Precipitate ear was described as study drug residue.