TABLE 2.
Safety summary of nemonoxacin in Phase II/III clinical studies.
| AEs incidences | NEMO-500 mg (n = 519) | NEMO-750 mg (n = 151) | NEMO total (n = 670) | LEVO-500 mg (n = 317) | RD [95%CI] | |
|---|---|---|---|---|---|---|
| NEMO-500 mg VS. LEVO-500 mg | NEMO-750 mg VS. LEVO-500 mg | |||||
| AEs a | 193 (37.2) | 82 (54.3) | 275 (41.0) | 123 (38.8) | 1.6 [−5.2; 8.4] | 15.5 [5.9; 25.1] |
| Drug-related AEs | 119 (22.9) | 45 (29.8) | 164 (24.5) | 68 (21.5) | 1.5 [−4.3; 7.3] | 8.4 [−0.2; 16.9] |
| Drug-related AEs led to study drug discontinuation | 2 (0.4) | 2 (1.3) | 4 (0.6) | 1 (0.3) | 0.1 [−0.8; 0.9] | 1.0 [−0.9; 2.9] |
| SAEsb | 12 (2.3) | 6 (4.0) | 18 (2.7) | 3 (0.9) | 1.4 [−0.3; 3.0] | 3.0 [−0.3; 6.3] |
| Drug-related SAEs | 1 (0.2) | 0 | 1 (0.1) | 0 | — | — |
| Deaths | 1 (0.2) | 1 (0.7) | 2 (0.3) | 0 | — | — |
| Study drug-related AEs leading to deaths | 0 | 0 | 0 | 0 | — | — |
a
AE, refers to unexpected and adverse medical events, including clinically significant clinical laboratory abnormalities, that are related to any medical measures in the study, whether related to the study medication or not. (Same definition in full text).
b
SAE refers to events occurring during the clinical trial that require hospitalization, prolong hospital stay, disability, affect work ability, endanger life or death, and cause congenital malformations. (Same definition in full text)