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Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet] Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2021 Apr.

Cover of Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC)

Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet]

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Abbreviations

AE: adverse event
AESI: adverse event of serious interest
BIA: business impact analysis
CCC: Crohn’s and Colitis Canada
CD: Crohn disease
CDAI: Crohn’s Disease Activity Index
CDEC: CADTH Canadian Drug Expert Committee
CI: confidence interval
CMH: Cochran-Mantel-Haenszel
CRP: C-reactive protein
EQ-5D: EuroQol 5-Dimensions questionnaire
EQ-5D-3L: EuroQol 5-Dimensions 3-Levels questionnaire
FAS: full analysis set
GI: gastrointestinal
HCP: health care provider
HRQoL: health-related quality of life
IBD: inflammatory bowel disease
IBDQ: Inflammatory Bowel Disease Questionnaire
IL: interleukin
ITC: indirect treatment comparison
ITT: intention-to-treat
IV: intravenous
IWRS: interactive web response system
MAdCAM-1: mucosal addressin cell adhesion molecule 1
MCID: minimal clinically important difference
NMA: network meta-analysis
OLE: open-label extension
pCPA: pan-Canadian Pharmaceutical Alliance
PPS: per-protocol set
q.w.: every week
q.2.w.: every 2 weeks
RCT: randomized controlled trial
SAE: serious adverse event
SAF: safety analysis set
SC: subcutaneous
SEB: subsequent entry biologic
TEAE: treatment-emergent adverse event
TNF alpha: tumour necrosis factor alpha
UC: ulcerative colitis
ULN: upper limit of normal
VAS: Visual Analogue Scale
WPAI-CD: Work Productivity and Activity Impairment–Crohn’s disease

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Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

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Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet] Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2021 Apr. Abbreviations.
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Abbreviations - Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC)
Abbreviations - Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC)
EXCLUDED STUDIES - Glycerol Phenylbutyrate (Ravicti)
EXCLUDED STUDIES - Glycerol Phenylbutyrate (Ravicti)
LITERATURE SEARCH STRATEGY - Glycerol Phenylbutyrate (Ravicti)
LITERATURE SEARCH STRATEGY - Glycerol Phenylbutyrate (Ravicti)
SUMMARY OF EFFICACY AND SAFETY RESULTS IN THREE SHORT-TERM, NON-RANDOMIZED STUDI...
SUMMARY OF EFFICACY AND SAFETY RESULTS IN THREE SHORT-TERM, NON-RANDOMIZED STUDIES: UP 1204-003, HPN-100-005, AND HPN-100-012 - Glycerol Phenylbutyrate (Ravicti)
DETAILED OUTCOME DATA - Ustekinumab (Stelara)
DETAILED OUTCOME DATA - Ustekinumab (Stelara)

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Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet]

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