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Posted On: 07/01/2020 1:08:39 PM
Post# of 145249
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Re: craigakess #40371
My take on that point was that any death in a trial is considered a severe adverse event that is recorded. Once the trial is unblinded, then you can know whether that event happened to a drug patient or a placebo patient. Then I think there is a further determination as to whether the drug contributed to the death of the drug patient. Just my two cents.
but, I agree, I cringed when he used that word / phrase. that phrase is normally used to mean something that is caused by the drug, which obviously cannot be the case as long as the trial is blinded.
but, I agree, I cringed when he used that word / phrase. that phrase is normally used to mean something that is caused by the drug, which obviously cannot be the case as long as the trial is blinded.
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