Status:
COMPLETED
Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborating Sponsors:
Institute of Cardiometabolism and Nutrition, France
Vanderbilt University
Conditions:
Myocarditis
Cardiac Complication
Eligibility:
All Genders
18+ years
Brief Summary
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatmen...
Detailed Description
ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, irAEs can occur. Here the inv...
Eligibility Criteria
Inclusion
- Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
- Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
- Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
Exclusion
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
December 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03387540
Start Date
December 2 2017
End Date
December 31 2017
Last Update
September 26 2019
Active Locations (1)
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1
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France, 75013