Monitoring
toxicity
EVENTS
The External Data and Safety Management Board (EDSMB) safeguards the interests of the trial participants, assesses the safety and efficacy of the interventions during the study, and monitors the overall conduct. The EDSMB will evaluate the toxicity data every three patients. All collected data is monitored by an independent, external data monitor. Severe adverse (device) events will be reported to the Medical Ethical Committee of the University Medical Center Utrecht and the EDSMB.