Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT03047031
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group III - pirfenidone patients Pirfenidone - Group II- pirfenidone patients Pirfenidone - All nintedanib treated patients (group B + group C) Nintedanib -
- Primary Outcome Measures
Name Time Method Incidence Rate of All ADRs in Nintedanib Treated Patients 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 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.
- Secondary Outcome Measures
Name Time Method 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 Adverse Events (AEs) causing dose interruption of study drug is reported.
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 Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.
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. Percentage of patients with adverse events (AEs) leading to permanently discontinuation of study drug is reported.
Percentages are rounded to one decimal places.
Trial Locations
- Locations (8)
P.D. Hinduja National Hospital
🇮🇳Mumbai, India
Asthma Bhawan
🇮🇳Jaipur, India
CK Birla Hospitals, The Calcutta Medical Research Institute
🇮🇳Kolkata, India
Midland Healthcare and Research Centre
🇮🇳Lucknow, India
King George Medical University
🇮🇳Lucknow, India
National Allergy Asthma Bronchitis Institute, Kolkata
🇮🇳Kolkatta, India
Bhatia Hospital
🇮🇳Mumbai, India
Grant Medical Foundation, Ruby Hall Clinic
🇮🇳Pune, India