Drug Evaluation Committee 2013-54 Handling of SAE Reporting for Hospitalization for Planned Surgery (Part 2)
Related classification: Adverse drug reaction reports
First published: March 2014
Question
A subject suffered a fracture during a clinical trial and was hospitalized for treatment, which was reported as an SAE. Ten months later, the subject was hospitalized again for removal of a bolt for intra-fracture fixation. The sponsor was of the opinion that the hospitalization for removal of the bolt was a planned hospitalization since the previous hospitalization and therefore could be listed as an AE rather than an SAE.
I understand that a treatment hospitalization that was scheduled prior to the start of the clinical trial is not an SAE, but do I have to list the second hospitalization that was scheduled after the first hospitalization, after the start of the clinical trial, as an SAE? Also, how should I handle this hospitalization for bolt removal?
Pharmaceutical Association's Opinion
The events that should be listed as adverse events and the method of reporting them may be stipulated separately in the study protocol, or each company may have its own rules on how to handle such events.
In general, bolt implantation and removal for treatment of fractures is a series of procedures, and if the patient is hospitalized only for removal as planned in advance without recurrence or exacerbation of symptoms, the hospitalization (for bolt removal) is not considered a new serious adverse event/adverse event even if the hospitalization was decided after the start of the trial. In this case, the hospitalization for the removal of the bolt is not considered to be a new serious adverse event/adverse event. In this case, it may be considered as an additional report to the report of a serious adverse event at the time of hospitalization for bolt implantation.