A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hutchmed
- 入组人数
- 3,005
- 试验地点
- 1
- 主要终点
- Incidence of ADRs
研究概览
简要总结
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
详细描述
This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).
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
- •Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week;
- •Provision of informed consent by the patient.
排除标准
- •Unsuitable for the study according to investigator's judgement.
研究组 & 干预措施
Cohort 1
- Currently using Elunate® or will use Elunate®(Fruquintinib) within a week;
- Provision of informed consent by the patient.
干预措施: Elunate® (Drug)
结局指标
主要结局
Incidence of ADRs
时间窗: from the first administration of fruquintinib up to 6 months
% of patients with ADRs according to CTCAE 4.03
Incidence of AEs
时间窗: from the first administration of fruquintinib up to 6 months
% of patients with AEs according to CTCAE 4.03
Incidence of SAEs
时间窗: from the first administration of fruquintinib up to 6 months
% of patients with SAEs according to CTC AE 4.03
Incidence of AESI
时间窗: from the first administration of fruquintinib up to 6 months
% of patients with AESI according to CTC AE 4.03
次要结局
未报告次要终点