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iwfal

02/24/12 1:22 AM

#137759 RE: masterlongevity #137758

anyone else have examples of composite endpoints used in successful ph 3 trials, for non CV indications?



Sure - Belimumab for Lupus probably qualifies as one of the most complicated ever.

Also note that I am not sure I would call logical ANDs of different severities of the same type of event a real composite since they don't necessitate the strange equating of different kinds of events. In contrast, try to explain in English the proved benefit of Belimumab and why being 1% worse on x was considered equal and offsetting to a 2% benefit on y. (Note that this isn't meant to be a condemnation of Belimumab - only that true composites, especially within individual patients, are rare for a reason.)

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genisi

02/24/12 5:51 AM

#137767 RE: masterlongevity #137758

Phase III trials of linaclotide in IBS-c had primary composite endpoint of Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder