Safety of Nintedanib in Real World in China

Boehringer Ingelheim

Overview

The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.

Study Type

OBSERVATIONAL

Conditions

Pulmonary Fibrosis

Interventions

nintedanibDRUG

nintedanib

pirfenidoneDRUG

pirfenidone

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who initiate nintedanib during the study period * Patients who initiate pirfenidone during the study period * Patients who use neither nintedanib nor pirfenidone * Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment * Patients who are 40 years old and above when enrolled * Patients who are willing to participate in the study and sign the informed consent form

Outcomes

Primary Outcomes

Incidence rate of adverse drug reactions (ADRs) during entire follow-up period

Time frame: During entire follow-up period, up to 1 year

Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date

Time frame: During follow-up period after index date, up to 1 year

Incidence rate of fatal adverse events (AEs) during entire follow-up period

Time frame: During entire follow-up period, up to 1 year

Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date

Time frame: During follow-up period after index date, up to 1 year

Secondary Outcomes

Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug

Time frame: At baseline

Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug

Time frame: At baseline

Data from ClinicalTrials.gov

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