TABLE 6.
Numbers and types of adverse events in subjects receiving single or multiple doses of finafloxacin or placeboa
| Study part and dose (mg) | NS | NS with AE | No. of AE | No. of AE related to study drug | Type of AE |
|||
|---|---|---|---|---|---|---|---|---|
| GI | RTI | NS | Other | |||||
| Part A | ||||||||
| 200 | 6 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
| 400 | 6 | 2 | 2 | 2 | 2 | 0 | 0 | 0 |
| 600 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 800 | 6 | 2 | 2 | 0 | 0 | 0 | 0 | 2 |
| 1,000 | 6 | 2 | 2 | 1 | 0 | 1 | 0 | 1 |
| Placebo | 15 | 3 | 4 | 2 | 1 | 1 | 0 | 2 |
| Part B | ||||||||
| 600 | 16 | 9 | 17 | 9 | 2 | 0 | 6 | 9 |
| 800 | 8 | 6 | 20 | 13 | 4 | 1 | 5 | 10 |
| 1,000 | 8 | 6 | 19 | 10 | 5 | 2 | 2 | 10 |
| Placebo | 8 | 5 | 18 | 13 | 5 | 0 | 3 | 10 |
a
The numbers and types of adverse events (AE) in subjects receiving single (part A) or multiple (part B) 1-h infusions of 200 to 1,000 mg finafloxacin are indicated. NS, number of subjects; GI, gastrointestinal; RTI, respiratory tract infections; NS, nervous system; Other, other types of AEs, including local reactions to intravenous catheters and skin, musculoskeletal, vascular, metabolic, psychiatric, and respiratory disorders.