Table 3. Related Adverse Events Registered in the Safety Population.
| Characteristic | Patients, No. (%) | ||
|---|---|---|---|
| CIPRO+FLUO (n = 196) | CIPRO (n = 195) | FLUO (n = 100) | |
| Patients with at least 1 adverse eventa | 6 (3.1) | 5 (2.6) | 0 |
| Related adverse events | 6 (3.1) | 9 (4.6) | 0 |
| Otic events | |||
| Cerumen impaction | 1 (0.5) | 0 | 0 |
| Ear pruritus | 0 | 2 (1.0) | 0 |
| Application site pain | 4 (2.0) | 0 | 0 |
| Fungal ear infection | 1 (0.5) | 1 (0.5) | 0 |
| Nonotic events | |||
| Nausea | 0 | 1 (0.5) | 0 |
| Dizziness | 0 | 2 (1.0) | 0 |
| Headache | 0 | 2 (1.0) | 0 |
| Lethargy | 0 | 1 (0.5) | 0 |
Abbreviations: CIPRO, ciprofloxacin alone; CIPRO+FLUO, ciprofloxacin plus fluocinolone acetonide; FLUO, fluocinolone acetonide alone.
a
Three patients in the CIPRO group had more than 1 related adverse event.