Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

Bristol-Myers Squibb486 enrolled

Overview

A case series analysis of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.

Study Type

OBSERVATIONAL

Enrollment

486

Conditions

Encephalitis

Interventions

NivolumabBIOLOGICAL

Specified dose on specified days

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor Exclusion Criteria: * Encephalitis cases identified through literature reviews and not reported to the Sponsor * Encephalitis cases identified from company-sponsored observational studies with secondary data collection * Spontaneous reports not submitted directly to the Sponsor Other protocol-defined inclusion/exclusion criteria apply

Locations (1)

Local Institution

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Outcomes of Encephalitis

Time since onset of immune-mediated encephalitis to the date of outcome assessment (days) and outcomes defined as: resolved, resolving, death, physical disability (specified), cognitive disability (specified)

Time frame: 1 year

Risk factors of Encephalitis

Potential risk factors include but are not limited to medical history including event associated signs/symptoms, and data from brain imaging diffusion, results from lumbar puncture analyses, results from serum sample analyses and results from neurologic examinations

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.