Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

N/AActive Not RecruitingNCT04325217

Boehringer Ingelheim586 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

586

Conditions

Lung Diseases, Interstitial

Interventions

NintedanibDRUG

Capsules

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * None.

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of adverse drug reactions (ADRs)

Focus on gastrointestinal symptoms including diarrhea and nausea

Time frame: up to 3 years and 9 months

Data from ClinicalTrials.gov

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