Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).
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
- •Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
排除标准
- •Diagnosis of Idiopathic Pulmonary Fibrosis
- •Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
研究组 & 干预措施
Ofev Capsules
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
干预措施: Nintedanib (Drug)
结局指标
主要结局
Incidence of Adverse Drug Reactions (ADRs)
时间窗: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.
Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'.
次要结局
未报告次要终点