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Wednesday, December 13, 2017 7:05:09 PM
Active Relative to Placebo
This is the key measure – 28.5% in mITT and 38.7% PP
([incidence control - incidence active]/incidence control)
Good spread (prevention) and may improve further in a Ph3 if placebo rate falls more in line w historical norms of 70-75% (can even be higher in HNC) – this assumes B-OM active arm stays constant -- though active arm may perform better too
So ideal would be placebo does worse and active does better = greater spread as Prevention efficacy
“Overall reduction in observed severe Oral Mucositis (WHO Grade ≥ 3) in the Brilacidin-OM treatment group from that seen in the control group ([incidence control - incidence active]/incidence control) was: 28.5% (mITT population) and 38.7% (PP population).”
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