Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

Boehringer Ingelheim425 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

425

Conditions

Lung Diseases, Interstitial

Interventions

NintedanibDRUG

Ofev Capsules as prescribed by the treating physician

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of Adverse Drug Reactions (ADRs)

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'.

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.

Data from ClinicalTrials.gov

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