10.1371/journal.pone.0044503.t005 Bregje J. W. Thomassen Bregje J. W. Thomassen Peter Pilot Peter Pilot Vanessa A. B. Scholtes Vanessa A. B. Scholtes Josef G. Grohs Josef G. Grohs Ketil Holen Ketil Holen Elvira Bisbe Elvira Bisbe Rudolf W. Poolman Rudolf W. Poolman Reported serious<sup>1</sup> adverse events. Public Library of Science 2012 adverse 2012-09-13 02:09:17 Dataset https://plos.figshare.com/articles/dataset/_Reported_serious_1_adverse_events_/247757 1<p>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.</p>