Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03047031

Enrollment

Registered

2017-02-08

Start date

2017-04-05

Completion date

2022-07-21

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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.

Interventions

DRUGNintedanib

Nintedanib

DRUGPirfenidone

Pirfenidone

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.

Countries

India

Participant flow

Recruitment details

This active surveillance study aimed to collect the safety data of Idiopathic Pulmonary Fibrosis (IPF) patients who were treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017).

Pre-assignment details

No patients were enrolled in Group A (nintedanib) & Group I (pirfenidone). The nintedanib patients in group B and group C were combined together in the participant flow and baseline characteristics, since the outcome measures and the adverse events were planned in the protocol of the study to be reported for all nintedanib treated patients.

Participants by arm

Arm	Count
All Nintedanib Treated Patients (Group B + Group C) This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.	14
Group II- Pirfenidone Patients This arm includes patients who started treatment with pirfenidone after the 23rd of January 2017 and are continuing the drug treatment at the time of participation in the active surveillance.	4
Group III - Pirfenidone Patients This arm includes patients who were newly prescribed with pirfenidone at the time of participation in the active surveillance.	3
Total	21

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	0	0
Overall Study	Change to other medication	2	0	0
Overall Study	Lost to Follow-up	4	0	0
Overall Study	Other than listed	1	0	0
Overall Study	Patient refusal to continue taking trial medication	2	0	0
Overall Study	Patients were not followed as planned in the protocol	0	4	3
Overall Study	Withdrawal by Subject	2	0	0

Baseline characteristics

Characteristic	All Nintedanib Treated Patients (Group B + Group C)	Group II- Pirfenidone Patients	Group III - Pirfenidone Patients	Total
Age, Continuous	64.7 Years STANDARD_DEVIATION 9.59	65.3 Years STANDARD_DEVIATION 4.57	68.0 Years STANDARD_DEVIATION 12.29	65.3 Years STANDARD_DEVIATION 8.91
Race and Ethnicity Not Collected	—	—	—	0 Participants
Sex: Female, Male Female	6 Participants	0 Participants	0 Participants	6 Participants
Sex: Female, Male Male	8 Participants	4 Participants	3 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 14
other Total, other adverse events	7 / 14
serious Total, serious adverse events	1 / 14

Outcome results

Primary

Incidence Rate of All ADRs in Nintedanib Treated Patients

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.