Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting One or More Adverse Events (AEs)
研究概览
简要总结
The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.
详细描述
Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required.
This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g "Takeda," hereinafter referred to as "the drug") was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have been confirmed as receiving the drug
排除标准
- 未提供
研究组 & 干预措施
Fomepizole Intravenous Infusion
Fomepizole Intravenous Infusion
干预措施: Fomepizole (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Events (AEs)
时间窗: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Had One or More Adverse Drug Reactions
时间窗: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants Reporting One or More Serious Adverse Events (SAEs)
时间窗: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Number of Participants Who Had One or More Serious Adverse Drug Reactions
时间窗: From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.
Arterial Blood pH
时间窗: Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days)
pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported.
次要结局
未报告次要终点