Wed-30-12-2015, 09:37 AM
(Wed-30-12-2015, 09:33 AM)Caroline Wrote:(Wed-30-12-2015, 08:56 AM)Fred Wrote:(Wed-30-12-2015, 08:48 AM)Caroline Wrote: By the way, flushing can hardly be mentioned as an Adverse Event as it is quite common.
Quote:
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
FDA
I would class flushing as an adverse event.
In that case it is very odd that there were only two AE's in flushing.
It is very common that nearly everyone using Fumaric acid esters gets flushing.
And I don't think that the total population of the research is about three children.
Additional: if you consider that the best way to tell if the FAE is working is getting a flush, than you might consider it a wished Event and not an AE.
I don't have a clue what you are on about. I'm only giving the information you make of it what you will.