Safety of Nintedanib in Real World in China

Withdrawn

• Conditions: Pulmonary Fibrosis
• Interventions: Drug: nintedanib; Drug: pirfenidone

• Registration Number: NCT05676112
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Study Start: 2023-12-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nintedanib new users	nintedanib	-
Pirfenidone new users	pirfenidone	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date	During follow-up period after index date, up to 1 year
Incidence rate of fatal adverse events (AEs) during entire follow-up period	During entire follow-up period, up to 1 year
Incidence rate of adverse drug reactions (ADRs) during entire follow-up period	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	During follow-up period after index date, up to 1 year

Secondary Outcome Measures

Name	Time	Method
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	At baseline
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	At baseline