Methods of managing eosinophilic esophagitis
An eosinophilic, eosinophilic technology applied in the field of management of eosinophilic esophagitis, which can solve problems such as dysphagia and loss of esophageal function
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Embodiment 1
[0376] Example 1 - PROSE device
[0377] Data for the PRO assessment (also referred to herein as the PROSE device) were collected over a 28-day baseline. Days -28 to -15 and -14 over two 14-day periods by generating counts identifying items (eg, number of episodes, source of problem, and remedy) or by taking graded averages (eg, difficulty, pain, and discomfort) Up to -1 days, the item data (itemdata) is aggregated. Baseline was defined as the period of 14 days immediately preceding the day of randomization (ie, Study Days -14 to -1). The Week 12 assessment was defined as the 14-day period immediately preceding the Week 12 visit (ie, Study Days 71 to 84). The change from baseline to week 12 in all PROSE scores was defined as the week 12 value minus the baseline value.
[0378] Combinations of the following individual question scores were calculated:
[0379] • If the subject reported not having any entries in the past 24 hours, the number of different food types consumed...
Embodiment 2
[0433] Example 2 - Co-primary endpoint for EoE using the PROSE device
[0434] Recommended endpoints for treatment of EoE include a co-primary endpoint measuring improvement in symptoms and a histologic endpoint. Using the PROSE questionnaire, the following endpoints were assessed:
[0435] Mean seizure symptom summary grade. This is the average of all episodes based on the 14-day mean of the three symptom grades for the following questions:
[0436] 1. How difficult was it for you to swallow [food / pill]?
[0437] 2. What was the worst pain you felt when you tried to swallow [food / pill]?
[0438] 3. When you tried to swallow [food / pill], what was the worst level of discomfort you experienced?
[0439] Maximal seizure summary grading. This is the average of the daily maximum means over 14 days for the three symptom ratings based on the following questions:
[0440] 1. How difficult was it for you to swallow [food / pill]?
[0441] 2. What was the worst pain you felt when...
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