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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04898751
Eligibility Criteria:
Inclusion Criteria:
* Treated with either Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).
* Developed an adverse reaction that was submitted to a pharmacovigilance center and was determined to be related to aforementioned immune checkpoint inhibitors.
* Adverse reaction was determined to be within the System Organ Class (SOC) "Skin and subcutaneous disorder".
Exclusion Criteria:
* Adverse event was determined not to be immune-related (for example, infectious etiology) or was a symptom (e.g., edema).
* Adverse event developed before the administration of ICI.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04898751
Study Brief:
Protocol Section:
NCT04898751