Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:0931df2badaa3788046a9a2c6d6045bc]
The primary objective of the study is to characterize the safety profile of MYDICAR. Safety outcomes will include proportion of subjects who complete the study; adverse event incidence, severity and relationship to investigational medicinal product or cardiac catheterization procedure; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations, ambulatory worsening of heart failure, myocardial infarction, stroke, mechanical circulatory support device (MCSD) implantation, heart transplant, and death; changes from baseline in laboratory tests, 12-lead electrocardiogram, and physical examination including weight and vital signs; and changes from baseline in implantable cardioverter defibrillator interrogation parameters.
clinicaltrials_vocabulary:other outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:other-outcome]
Phase 1 and Phase 2: Safety profile of MYDICAR (proportion of subjects who complete the study; adverse event; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations 24 months [clinicaltrials_resource:0931df2badaa3788046a9a2c6d6045bc]
The primary objective of the study is to characterize the safety profile of MYDICAR. Safety outcomes will include proportion of subjects who complete the study; adverse event incidence, severity and relationship to investigational medicinal product or cardiac catheterization procedure; concomitant medication use and changes in heart failure-related medications; incidence and event rates of hospitalizations, ambulatory worsening of heart failure, myocardial infarction, stroke, mechanical circulatory support device (MCSD) implantation, heart transplant, and death; changes from baseline in laboratory tests, 12-lead electrocardiogram, and physical examination including weight and vital signs; and changes from baseline in implantable cardioverter defibrillator interrogation parameters.
Bio2RDF identifier
0931df2badaa3788046a9a2c6d6045bc
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:0931df2badaa3788046a9a2c6d6045bc
measure [clinicaltrials_vocabulary:measure]
Phase 1 and Phase 2: Safety pr ...... vent rates of hospitalizations
time frame [clinicaltrials_vocabulary:time-frame]
description
The primary objective of the s ...... ator interrogation parameters.
identifier
clinicaltrials_resource:0931df2badaa3788046a9a2c6d6045bc
title
Phase 1 and Phase 2: Safety pr ...... of hospitalizations 24 months
@en
type
label
Phase 1 and Phase 2: Safety pr ...... 1df2badaa3788046a9a2c6d6045bc]
@en