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>