Table_5.xls (5.5 kB)
Reported serious1 adverse events.
dataset
posted on 2012-09-13, 02:09 authored by Bregje J. W. Thomassen, Peter Pilot, Vanessa A. B. Scholtes, Josef G. Grohs, Ketil Holen, Elvira Bisbe, Rudolf W. Poolman1
Serious definition according to ICH/Good Clinical Practice as any untoward and unintended response that results in death, is immediately life-threatening, requires in-subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital abnormality or birth defect or is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above.
