Safety of Nintedanib in Real World in China

Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05676112

Enrollment

Registered

2023-01-09

Start date

2023-12-29

Completion date

2026-09-30

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

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.

Interventions

DRUGnintedanib

nintedanib

DRUGpirfenidone

pirfenidone

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026