Auspar attachment 3: Extract from the Supplementary Clinical Evaluation Report for Daclizumab



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List of common abbreviations


Abbreviation

Meaning

Ab

Antibody

AE

Adverse event

ANCOVA

Analysis of covariance

ARR

Annualised Relapse Rate

Avonex

IFN β-1a (tradename)

BBB

Blood-brain barrier

BG-12

Dimethyl fumarate

CD25

Interleukin-2 receptor, alpha subunit

CER

Clinical Evaluation Report

CI

Confidence interval

CNS

Central nervous system

DAC HYP

Daclizumab High Yield Process

DAC Penzberg

Daclizumab, Penzberg investigational form

EDSS

Expanded Disability Status Scale

EE

Efficacy-evaluable (population)

EEDS

Expanded Disability Status Scale

EMA

European Medicines Agency

Gd

Gadolinium

IFN

Interferon

IFN-β

Interferon beta

IgG

Immunoglobulin G

IL-2

Interleukin-2

IL-2Rα

Interleukin-2 receptor, alpha subunit

IM

Intramuscular

INEC

Independent Neurology Evaluation Committee

INEC

Independent Neurology Evaluation Committee

ISR

Injection site reaction

ITT

Intent-to-treat

IVRS

Interactive Voice Response System

JC

John Cunningham

LTi

Lymphoid tissue inducer (cells)

MAb

Monoclonal antibody

MRI

Magnetic Resonance Imaging

MS

Multiple sclerosis

MSFC

Multiple Sclerosis Functional Composite

MSIS-29

Multiple Sclerosis Impact Scale 29

NK

Natural killer (cells)

PD

Pharmacodynamic

PFS

Pre-filled syringe

PI

Product Information

PK

Pharmacokinetic

PPMS

Primary progressive multiple sclerosis

PRMS

Primary-relapsing multiple sclerosis

QoL

Quality of life

RRMS

Relapsing and remitting multiple sclerosis

SC

Subcutaneous(ly)

SCE

Summary of Clinical Efficacy

SCER

Supplementary Clinical Evaluation Report

SCS

Summary of Clinical Safety

SDMT

Symbol Digit Modalities Test

SOC

System organ class

SPMS

Secondary progressive multiple sclerosis

TGA

Therapeutic Goods Administration

VFT

Visual Function Test

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