Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date
研究概览
简要总结
The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who initiate nintedanib during the study period
- •Patients who initiate pirfenidone during the study period
- •Patients who use neither nintedanib nor pirfenidone
- •Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment
- •Patients who are 40 years old and above when enrolled
- •Patients who are willing to participate in the study and sign the informed consent form
排除标准
- 未提供
研究组 & 干预措施
Nintedanib new users
干预措施: nintedanib (Drug)
Pirfenidone new users
干预措施: pirfenidone (Drug)
结局指标
主要结局
Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date
时间窗: During follow-up period after index date, up to 1 year
Incidence rate of fatal adverse events (AEs) during entire follow-up period
时间窗: During entire follow-up period, up to 1 year
Incidence rate of adverse drug reactions (ADRs) during entire follow-up period
时间窗: During entire follow-up period, up to 1 year
Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date
时间窗: During follow-up period after index date, up to 1 year
次要结局
- Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug(At baseline)
- Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug(At baseline)