Drug Use Investigation On Zithromac Tablets 600mg In HIV Patients (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
- 476
- 主要终点
- Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
研究概览
简要总结
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown Adverse Drug Reactions and drug interactions and determining the factors affecting safety and efficacy.
详细描述
All the patients whom an investigator prescribes the first Zithromac Tablets 600mg 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
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered Zithromac Tablets 600mg in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Zithromac Tablets 600mg.
研究组 & 干预措施
Azithromycin
Patients taking Azithromycin.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
时间窗: 9 years(MAX)
Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Number of Participants With the Frequency of Treatment Related Adverse Events.
时间窗: 9 years(MAX)
Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
时间窗: 9 years(MAX)
Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether \<65 years or \>=65 years is significant risk factor.
次要结局
- Number of Participants That Responded to Azithromycin Treatment.(9 years(MAX))
- Number of Participants Prevented by Azithromycin Treatment.(9 years(MAX))