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Table 2 Participant withdrawal criteria

From: A randomised controlled trial evaluating arrhythmia burden, risk of sudden cardiac death and stroke in patients with Fabry disease: the role of implantable loop recorders (RaILRoAD) compared with current standard practice

Withdrawal criteria
Participant’s withdrawal of consent
An adverse event (AE) or serious adverse event (SAE) requiring withdrawal from study (determined by CERC)
Substantial protocol deviation
Investigator or sponsor decision