Specific post-marketing surveillance of Geninax(R) Tablets 200 mg Efficacy and safety against bacterial pneumonia
- Conditions
- Bacterial pneumonia
- Registration Number
- JPRN-UMIN000012124
- Lead Sponsor
- Toyama Chemical Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method