N/A
Completed N=70
Safety and Effectiveness of Nintedanib in Korean Patients
Source: ClinicalTrials.gov NCT04525547 ↗Enrolled (actual)
70
Serious AEs
24.6%
Results posted
Mar 2024
Primary outcomePrimary: Number of Patients With Adverse Events Who Took at Least One Dose of Ofev — 36 Participants
Summary
The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events Who Took at Least One Dose of Ofev |
36 | — |
| PRIMARY Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment |
-15.00 | 0.8170 |
| PRIMARY Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment |
-44.00 | 0.6533 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04525547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.