Why the study?
Disturbances of cardiac rhythm are frequently observed during continuous ECG monitoring in normal healthy adults in clinical pharmacology studies, but their clinical significance is often difficult to assess.
How should cardiac arrhythmias observed during continuous ECG monitoring in normal healthy adults in clinical pharmacology studies be interpreted and reported?
Population
Normal healthy adults in clinical pharmacology studies
Design
Guideline for interpretation and reporting of cardiac arrhythmias
Authors
Loading...
Rhythm disturbances in first-in-human studies warrant cautious interpretation; leaves open their clinical significance for drug safety.
How should cardiac arrhythmias observed during continuous ECG monitoring in normal healthy adults in clinical pharmacology studies be interpreted and reported?
Provides guidelines for interpreting and reporting cardiac arrhythmias detected by continuous ECG monitoring in healthy adults during phase 1 clinical pharmacology studies.
Bernard E. Ilson (1995) conducted a review in Normal healthy adults. Continuous electrocardiogram monitoring was evaluated. Continuous electrocardiogram monitoring in normal healthy adults frequently reveals arrhythmias, though greater than 50 PVCs per 24 hours and greater than 100 PACs per hour are relatively rare.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: