Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia - Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
研究概览
简要总结
The safety in 730 patients and the efficacy in 535 patients were examined. The efficacy rate of garenoxacin for bacterial pneumonia was 92.8% (479/516 patients). The eradication rates for Streptococcus pneumoniae and Haemophilus influenzae, the major pathogens of bacterial pneumonia, were 98.5% (65/66 strains) and 100% (65/65 strains), respectively. The incidence of adverse drug reactions (including abnormal laboratory tests) was 7.9% (58/730 patients). Among the main adverse drug reactions, abnormal laboratory tests were observed in 2.1% patients (15/730), hepatobiliary disorders were observed in 1.8% patients (13/730), and skin and subcutaneous tissue disorders were observed in 1.6% patients (12/730).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who had a history of hypersensitivity to Geninax(R) Tablets or other quinolones Patients who were pregnant or possibly pregnant or were lactating Patients who were previously enrolled in the study Patients in whom drug efficacy of Geninax(R) Tablets was difficult to assess Other patients whom the primary physician deems to be ineligible as a target
