TABLE 2.
Common drug-related adverse events in the single-dose tolerability study of i.v. nemonoxacin
| Adverse event | Placebo (pooled n = 24) | No. (%) of subjects with indicated adverse event at a dosage ofa: |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 25 mg (0.42) (n = 4) | 50 mg (0.83) (n = 4) | 125 mg (2.08) (n = 6) | 250 mg (4.17) (n = 6) | 250 mg (5.56) (n = 6) | 500 mg (8.33) (n = 6) | 750 mg (4.17) (n = 6) | 750 mg (5.56) (n = 6) | 750 mg (8.33) (n = 6) | 1,000 mg (4.17) (n = 6) | 1,000 mg (5.56) (n = 6) | 1,250 mg (4.17) (n = 6) | Total (n = 68) | ||
| Injection site reaction | 1 (4) | 0 (0) | 1 (25) | 0 (0) | 4 (67) | 4 (67) | 5 (83) | 1 (17) | 1 (17) | 4 (67) | 3 (50) | 1 (17) | 3 (50) | 27 (40) |
| Erythematous rash with or without pruritus | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (67) | 3 (50) | 1 (17) | 3 (50) | 0 (0) | 1 (17) | 1 (17) | 13 (19) |
| Abnormal electrocardiogram T-wave | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (50) | 0 (0) | 3 (4) |
a
Values in parentheses immediately after the dosages are the infusion rates (in mg/min).