Percentage of Participants With a Clinical Response Baseline and Week 8 [clinicaltrials_resource:a7861f3c55408a91ecf853c2d837d148]
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]
Percentage of Participants With a Clinical Response Baseline and Week 8 [clinicaltrials_resource:a7861f3c55408a91ecf853c2d837d148]
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
Bio2RDF identifier
a7861f3c55408a91ecf853c2d837d148
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:a7861f3c55408a91ecf853c2d837d148
measure [clinicaltrials_vocabulary:measure]
Percentage of Participants With a Clinical Response
time frame [clinicaltrials_vocabulary:time-frame]
Baseline and Week 8
description
Clinical response is defined a ...... fore range from 0 to13 points.
identifier
clinicaltrials_resource:a7861f3c55408a91ecf853c2d837d148
title
Percentage of Participants With a Clinical Response Baseline and Week 8
@en
type
label
Percentage of Participants Wit ...... 61f3c55408a91ecf853c2d837d148]
@en