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