An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Incidence Rate of All ADRs in Nintedanib Treated Patients
研究概览
简要总结
This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017).
- •Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients).
- •Patients in whom data collection is possible from the medical records (applicable for Group A and B patients)
- •Further inclusion criteria apply
排除标准
- •Patients who were previously treated with nintedanib.
- •Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone..
- •Patients who are participating in a clinical trial.
- •Further exclusion criteria apply.
研究组 & 干预措施
All nintedanib treated patients (group B + group C)
干预措施: Nintedanib (Drug)
Group II- pirfenidone patients
干预措施: Pirfenidone (Drug)
Group III - pirfenidone patients
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Incidence Rate of All ADRs in Nintedanib Treated Patients
时间窗: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event. Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as \[100 patient-years (pt-yrs)\]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.
Incidence Rate of All SAEs in Nintedanib Treated Patients
时间窗: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Incidence rate of all Serious Adverse Events (SAEs) in nintedanib treated patients is reported. A SAE was defined as any adverse event which: * results in death, * is life-threatening, * requires in-patient hospitalization, or * prolongation of existing hospitalisation, * results in persistent or significant disability or incapacity, or * is a congenital anomaly/birth defect. Incidence rate was calculated using the number of patients with SAEs events per treatment divided by time at risk expressed as \[100 patient-years (pt-yrs)\]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.
次要结局
- Percentage of Patients With AEs Causing Dose Interruption of Study Drug(From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.)
- Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug(From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.)
- Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug(From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.)