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Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX): (Allergan Inc.): Indication: For the prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting four hours a day or longer) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Nov.

Cover of Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX)

Clinical Review Report (Resubmission): OnabotulinumtoxinA (BOTOX): (Allergan Inc.): Indication: For the prophylaxis of headaches in adults with chronic migraine (≥ 15 days per month with headache lasting four hours a day or longer) [Internet].

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Abbreviations

ACM-S

Assessment of Chronic Migraine Symptoms Questionnaire

ACM-I

Assessment of Chronic Migraine Impacts Questionnaire

ADL-I

Activities of Daily Living Impact

AE

adverse event

BLOCF

baseline observation carried forward

CDEC

CADTH Canadian Drug Expert Committee

CDR

CADTH Common Drug Review

CI

confidence interval

CM

chronic migraine

CrI

credible interval

DB

double-blind

EMO-I

Emotions Impact

ENE-I

Energy Impact

GEN-I

General Impact

HIT

Headache Impact Test

HOS-I

Household Activities Impact

HRQoL

health-related quality of life

HRU

health care resource utilization

ICHD-III

International Classification of Headache Disorders 3rd Edition

ITT

intention-to-treat population

IVRS

interactive voice response system

LEA-I

Leisure Activities Impact

LOCF

last observation carried forward

MCID

minimal clinically important difference

MD

mean difference

MIBS

Migraine Interictal Burden Scale

mLOCF

modified last observation carried forward

MOH

medication overuse headache

MSQ

Migraine-Specific Quality of Life Questionnaire

MSQv2.1

Migraine-Specific Quality of Life Questionnaire, version 2.1

OLE

open-label extension

Ona A

onabotulinumtoxinA

PHQ-9

Patient Health Questionnaire

PP

per-protocol

QoL

quality of life

RCT

randomized controlled trial

SAE

serious adverse event

SD

standard deviation

SES

Symptom Experience Score

SOC-I

Social Impact

SSS

Symptom Severity Score

WDAE

withdrawal due to adverse event

WOCF

worst observation carried forward

WPAI-SHP

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem

WS-I

Work/School Impact

Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

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/

Bookshelf ID: NBK565155
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