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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (2927)	11/3/2013 7:13:40 AM
From: GregorioAllegri	Read Replies (1) \| Respond to of 4474

You are quite right about the differences reported at the various scientific meetings and the literature and what is in the US Label and the recent FDA press releases. That discrepancy cost me a small fortune. The phase I data was last updated at ASCO this year and made no mention of hypertension or cardiovascular events. Yet the FDA put out a startling number of >40% last week. Apparently the company has only been doing the testing for this recently after this became a concern... (???) ga

To: Biomaven who wrote (2927)	11/3/2013 12:17:12 PM
From: jq1234si	Respond to of 4474

From Iclusig label. There are many ways to report AEs, as I mentioned before on iHUB, one typical is treatment emergent vs treatment related. The numbers I cited is treatment emergent which includes all AEs occurred after treatment start - for those with pre-existing conditions, only those that are getting worse are counted as treatment emergent AEs. For safety evaluation, in general, it is better to use treatment emergent because investigator's assessment regarding "related" to drugs are often unreliable, not only because of possible bias but also because of difficulty in making judgment at the time of events. For example, investigators quite often contribute AEs to true placebo in double blinded trials.