Safety and Effectiveness of Nintedanib in Korean Patients

Boehringer Ingelheim70 enrolled

Overview

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

NintedanibDRUG

Nintedanib

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have been started on Ofev in accordance with the approved label in Korea * Patients who have signed on the data release consent form Exclusion Criteria: * Patients for whom nintedanib is contraindicated according local label of Ofev * Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients * Women who are pregnant or nursing * Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment

Locations (22)

Dong-A University Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Number of Patients With Adverse Events Who Took at Least One Dose of Ofev

Number of patients with adverse events who took at least one dose of Ofev is presented.

Time frame: Up to 24 weeks.

Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment

Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.

Time frame: At baseline and at week 12.

Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment

Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.

Time frame: At baseline and at week 24.

Data from ClinicalTrials.gov

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