N/A
Completed N=21
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov NCT03047031 ↗Enrolled (actual)
21
Serious AEs
7.1%
Results posted
Aug 2024
Primary outcomePrimary: Incidence Rate of All ADRs in Nintedanib Treated Patients — 11.0 patients with ADR events/100 pt-years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of All ADRs in Nintedanib Treated Patients |
11.0 | — |
| PRIMARY Incidence Rate of All SAEs in Nintedanib Treated Patients |
11.4 | — |
| SECONDARY Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug |
— | — |
| SECONDARY Percentage of Patients With AEs Causing Dose Interruption of Study Drug |
— | — |
| SECONDARY Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug |
7.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03047031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.