A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 22
- 主要终点
- Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
研究概览
简要总结
The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
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 who have been started on Ofev in accordance with the approved label in Korea
- •Patients who have signed on the data release consent form
排除标准
- •Patients for whom nintedanib is contraindicated according local label of Ofev
- •Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients
- •Women who are pregnant or nursing
- •Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
研究组 & 干预措施
Ofev treatment
Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))
干预措施: Nintedanib (Drug)
结局指标
主要结局
Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
时间窗: Up to 24 weeks.
Number of patients with adverse events who took at least one dose of Ofev is presented.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
时间窗: At baseline and at week 12.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
时间窗: At baseline and at week 24.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
次要结局
未报告次要终点