Table 5.
Number and frequency of subjects with drug-related TEAE (>2%) in the phase II clinical trial of nemonoxacin for treating community-acquired pneumonia
Adverse event | Number (%) of subjects
|
||
---|---|---|---|
Nemonoxacin 500 mg (n=89) | Nemonoxacin 750 mg (n=86) | Levofloxacin 500 mg (n=90) | |
Subjects with any drug-related TEAE | 27 (30.3) | 27 (31.4) | 27 (30.0) |
Neutropenia | 8 (9.0) | 8 (9.3) | 10 (11.1) |
Dizziness | 4 (4.5) | 3 (3.5) | 2 (2.2) |
Nausea | 1 (1.1) | 5 (5.8) | 3 (3.3) |
Diarrhea | 5 (5.6) | 1 (1.2) | 1 (1.1) |
Thrombocythemia | 2 (2.2) | 4 (4.7) | 1 (1.1) |
ECG QTc interval prolonged | 0 | 2 (2.3) | 3 (3.3) |
Blood amylase increased | 1 (1.1) | 1 (1.2) | 2 (2.2) |
Headache | 2 (2.2) | 1 (1.2) | 0 |
ALT increased | 2 (2.2) | 0 | 1 (1.1) |
AST increased | 2 (2.2) | 0 | 0 |
Note: Antimicrob Agents Chemother, 2010;54(10):4098–4106, doi: 10.1128/AAC.00295-10, amended with permission from American Society for Microbiology.30
Abbreviations: TEAE, treatment emergent adverse event; ECG, electrocardiogram; QTc, QT interval corrected; ALT, alanine aminotransferase; AST, aspartate aminotransferase.