Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab
Case Series Analyses of the Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab
1 other identifier
observational
486
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 30, 2022
June 1, 2022
5.1 years
August 2, 2016
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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
1 year
Study Arms (1)
Patients Treated with Nivolumab followed by Encephalitis Event
Case series reported to the sponsor from various health care facilities
Interventions
Specified dose on specified days
Eligibility Criteria
Case series reported to the sponsor from various health care facilities
You may qualify if:
- Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 4, 2016
Study Start
December 9, 2015
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 30, 2022
Record last verified: 2022-06