2013 of 2013
Randomization is closed!
effective February 19, 2018
The trial is monitored by a Data Safety Monitoring Board (DSMB).
All adverse events will be reported via the SAE manager, Ary Serpa Neto, to the DSMB.
The independent DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki, monitors patient safety and reviews safety issues as the study progresses. The primary mandate of the DSMB is to protect patient safety.
The SAE manager assesses the events and reports all related or possibly related events and all unexpected events to the DSMB for review.
The DSMB will review unblinded results on request. If adverse events of a particularly serious type are more common in the experimental arm compared to the control arm, then the DSMB may recommend termination of the study based on the evaluation of these results. This evaluation has to be made in consideration of risk/benefit.