Safety of Nintedanib in Real World in China

Boehringer Ingelheim

Status: Withdrawn

Conditions: Pulmonary Fibrosis

Treatments: Drug: nintedanib; Drug: pirfenidone

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05676112

1199-0412

Details and patient eligibility

About

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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 3 patient groups

Nintedanib new users

Treatment:

Drug: nintedanib

Pirfenidone new users

Treatment:

Drug: pirfenidone

no drug-treated users

Description:

subjects who did not receive nintedanib, pirfenidone