Agrylin Capsules 0.5 mg Drug Use-Result Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,826
- 试验地点
- 298
- 主要终点
- Number of Participants Who Had One or More Adverse Events
研究概览
简要总结
The objective of this survey is to collect data to evaluate the safety and efficacy of anagrelide hydrochloride in the post-marketing phase in participants diagnosed with Essential Thrombocythemia (ET).
详细描述
Anagrelide hydrochloride Drug Use-Result Survey
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 cases who received treatment with Agrylin.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Had One or More Adverse Events
时间窗: From start of study drug administration up to 12 months
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.
Percentage of Participants Who Responded in Platelet Count
时间窗: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants who responded in platelet count was assessed. A response was defined as platelet counts to \<60 x10\^4 platelet/mcrL beyond 3 months after the start of study drug administration.
Number of Participants Who Had One or More Serious Adverse Event
时间窗: From start of study drug administration up to 12 months
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 start of study drug administration up to 12 months
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.
Percentage of Participants With Normalization in Platelet Count
时间窗: From 3 months after the start of study drug administration, up to 12 months
Percentage of participants with normalization in platelet count was assessed. Normalization was defined as platelet counts to \<40 x10\^4 platelets/mcrL beyond 3 months after the start of study drug administration.
Number of Participants Who Had One or More Adverse Drug Reactions
时间窗: From start of study drug administration up to 12 months
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.
次要结局
- Percentage of Participants With at Least 50% Reduction in Platelet Count(From start of study drug administration up to 12 months)