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Wednesday, November 07, 2018 4:37:20 PM
Why do say that?
Are they forbidden to report causes of death
Oh, no--causes of death in the trial will be fully reported.
These numbers have NO relation to REDUCE IT, but as a thought experiment: Imagine if there are 700 all-cause deaths in the trial in a trial of a CV agent. So say 350 in each group. If the population is high risk CV, most of those deaths will be CV.
So say you're left with 100 patients in each group that died of a non-CV cause. Then you have to divvy those up by who died of what. So you're going to end up with very small cuts for individual causes of non-CV death. It doesn't mean much if, say, 47 people died of cancer in the Vascepa arm and 50 died of cancer in the placebo arm.
Also presumably it is not a prespecified analysis (meaning included in the study protocol). Which means even if there's a huge signal, it would be a post-hoc analysis and, as they say in publications "hypothesis-generating."
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