FIRAZYR General Drug Use-Results Survey (Japan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 179
- 试验地点
- 18
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.
- •Exclusion Criteria
排除标准
- 未提供
研究组 & 干预措施
Firazyr
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
干预措施: Firazyr (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Baseline up to end of the study (up to approximately 68 months)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants With Adverse Drug Reaction
时间窗: Baseline up to end of the study (up to approximately 68 months)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug.
Time to Treatment for Attack
时间窗: Up to 3 months
Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack was assessed and reported.
Time to First Symptom Relief
时间窗: Up to 3 months
Time to first symptom relief defined as the time between the first injection of treatment and first symptom relief. Time to first symptom relief was assessed and reported.
Time to Complete Resolution of Attack
时间窗: Up to 3 months
Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack was assessed and reported.
Total Duration of Attack
时间窗: Up to 3 months
Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack was assessed and reported.
次要结局
未报告次要终点