N/A
Completed N=408
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Lung Diseases, Interstitial
Source: ClinicalTrials.gov NCT04559581 ↗
Enrolled (actual)
408
Serious AEs
34.1%
Results posted
Feb 2026
Primary outcomePrimary: Incidence of Adverse Drug Reactions (ADRs) — 246 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Drug Reactions (ADRs) |
246 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04559581). 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.