Email from Leo on why the duration analysis was li

Email from Leo on why the duration analysis was limited.

cabel Wednesday, 01/03/18 01:53:50 PM
Re: None
Post #211320 of 211322

Got this back from Leo when I asked him about the PR this morning.

Quote:

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It's because we reduced incidences of SOM with Brilacidin, too few SOM patients were in the Brilacidin arm to make a statement about reduction that would be mathematically valid. Our primary goal is to prevent patients from getting SOM.

I tried my best to make it clear in the PR.
Duration of Severe Oral Mucositis: Given that Brilacidin-OM successfully prevented SOM from occurring, as well as delayed its onset, in a substantial number of patients, data comparisons aimed at assessing potential reduction in the duration of SOM were constrained by the fewer number of Brilacidin-OM treated patients that could be included in such analysis. While Brilacidin-OM appeared to decrease the initial duration of SOM (time from the initial WHO Grade ≥ 3 to the first WHO Grade ≤ 2 OM assessment), detailed interpretation of this and other duration data comparisons were limited.

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