Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52.Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported. Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders.
BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 to 10 ) and average daily stool frequency<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Why Should I Register and Submit Results?.
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