Tuesday, March 13, 2018 9:20:02 PM
I? trying to sort the following:
IPIX primary outcome measures as defined in clinicaltrials.gov:
A.
1. Incidence of severe oral mucositis (WHO Grade ≥3) [ Time Frame: 7 weeks ]
Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The WHO Score will be assessed by trained site personnel twice-weekly.
2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 11 weeks ]
Reporting of Adverse Events and severity of adverse events
B.
1. From the 2/7/18 10q, pg 23, third paragraph down:
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.
Based on the last eleven words of the last setence (¨detailed interpretation of this and other duration data comparisons were limited.¨), tells me there is more data analysis to come, hopefully.
How can something be conclusive if the interpretations are limited?
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