Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
Locations
Other Locations
Japan
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo
Time Frame
Start Date: 2020-05-27
Completion Date: 2026-09-30
Participants
Target number of participants: 586
Treatments
Patients newly initiating Ofev®/Nintedanib Capsules
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim