Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,004
- 主要终点
- Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.
研究概览
简要总结
Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
详细描述
All the patients whom an investigator prescribes the first Linezolid should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered Linezolid in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Linezolid.
研究组 & 干预措施
linezolid (Zyvox)
Patients taking Linezolid.
干预措施: linezolid (Zyvox) (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.
时间窗: Baseline to 8 weeks
The adverse drug reaction that have not been listed in Japanese package insert.
Number of Participants With Adverse Drug Reactions(ADRs).
时间窗: 8 weeks
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.
Factors Considered to Affect the Safety of Linezolid - Gender.
时间窗: 8 weeks
Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Age
时间窗: 8 weeks
Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.
时间窗: 8 weeks
Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.
时间窗: 8 weeks
Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.
时间窗: 8 weeks
Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Route of Administration.
时间窗: 8 weeks
Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Weight.
时间窗: 8 weeks
Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.
时间窗: 8 weeks
Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.
Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.
时间窗: 8 weeks
Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.
次要结局
未报告次要终点