Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02856451
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02856451
Study Brief:
Protocol Section:
NCT02856451