An observational study in Lung Diseases, Interstitial, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Boehringer Ingelheim · Observational
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.
646 studies on the registry are indexed under Lung Diseases, Interstitial; 237 are open to participants now.
This study's enrollment of 586 is above the median of 150 across 270 observational studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
As this is a non-interventional study, no specific treatment is mandated or withheld from the patients. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.
Exclusion Criteria:
Drug: Nintedanib
Capsules
Also known as: Ofev®
Incidence of adverse drug reactions (ADRs)
Focus on gastrointestinal symptoms including diarrhea and nausea
Time frame: up to 3 years and 9 months
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim