Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 425
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Drug Reactions (ADRs)
Study Overview
Brief Summary
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
Exclusion Criteria
- •Diagnosis of Idiopathic Pulmonary Fibrosis
- •Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
Arms & Interventions
Ofev Capsules
Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.
Intervention: Nintedanib (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Drug Reactions (ADRs)
Time Frame: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.
Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'.
Secondary Outcomes
No secondary outcomes reported