NCT04325217已完成不适用
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 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 confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-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 SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
排除标准
- 未提供
研究组 & 干预措施
Patients newly initiating Ofev®/Nintedanib Capsules
干预措施: Nintedanib (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs)
时间窗: up to 3 years and 9 months
Focus on gastrointestinal symptoms including diarrhea and nausea
次要结局
未报告次要终点
研究者
研究点 (1)
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