Drug Use Investigation Of Gabapen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,273
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 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 Gabapentin 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 taking Gabapentin in order to be enrolled in the surveillance
排除标准
- •Patients not taking Gabapentin
研究组 & 干预措施
Gabapentin
Patients taking Gabapentin
干预措施: Gabapentin (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: 12 weeks
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
时间窗: 12 weeks
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Clinical Efficacy Rate
时间窗: 12 weeks
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
次要结局
- Response Ratio (R Ratio)(12 weeks)
- Responder Rate(12 weeks)
- Percent Reduction From Baseline in Epileptic Seizure Frequency(12 weeks)