Assessment of safety
disability or incapacity, death
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Adverse (AEs) and serious adverse events (SAEs) will be recorded during this trial.An SAE is defined as any life-threatening adverse event, which requires or prolongs hospital stay, results in persistent or significant disability or incapacity, or results in death. Events occurring in the period from randomization to discharge must be documented and reported to the coordinating investigator within 5 days after they become apparent. All SAEs must be documented on a “serious adverse event form”.The form contains the following information: name of the attending physician, detailed description of the SAE, consequence for the trial, and dated signature of the attending physician.