Efficacy and Safety Study of Peginterferon Beta-1a in Par... | NCT00906399 | Trialant
NCT00906399
Sponsor
Biogen
Status
Completed
Last Update Posted
Sep 19, 2014Estimated
Enrollment
1,516Actual
Phase
Phase 3
Conditions
Relapsing Multiple Sclerosis
Interventions
BIIB017 (peginterferon beta-1a)
Placebo
Countries
United States
Belgium
Bulgaria
Canada
Chile
Colombia
Croatia
Czechia
Estonia
France
Georgia
Germany
Greece
India
Latvia
Mexico
Netherlands
New Zealand
Peru
Poland
Romania
Russia
Serbia
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00906399
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
105MS301
Secondary IDs
ID
Type
Description
Link
2008-006333-27
EudraCT Number
Brief Title
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Official Title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
Acronym
ADVANCE
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Sep 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2009
Primary Completion Date
Oct 2012Actual
Completion Date
Oct 2013Actual
First Submitted Date
May 20, 2009
First Submission Date that Met QC Criteria
May 20, 2009
First Posted Date
May 21, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 28, 2014
Results First Submitted that Met QC Criteria
Sep 15, 2014
Results First Posted Date
Sep 19, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 17, 2014
Certification/Extension First Submitted that Passed QC Review
Jun 17, 2014
Certification/Extension First Posted Date
Jun 20, 2014Estimated
Last Update Submitted Date
Sep 15, 2014
Last Update Posted Date
Sep 19, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
Detailed Description
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.
Conditions Module
Conditions
Relapsing Multiple Sclerosis
Keywords
interferon
injectable
MS
SC
PEGylated
Interferon beta-1a
relapsing
PEG
multiple sclerosis
subcutaneous
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,516Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
Drug: BIIB017 (peginterferon beta-1a)
Drug: Placebo
Peginterferon Beta-1a Q2W
Experimental
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
Drug: BIIB017 (peginterferon beta-1a)
Peginterferon Beta-1a Q4W
Experimental
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Drug: BIIB017 (peginterferon beta-1a)
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIIB017 (peginterferon beta-1a)
Drug
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Peginterferon Beta-1a Q2W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Annualized Relapse Rate (ARR) at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
1 Year
Secondary Outcomes
Measure
Description
Time Frame
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year
Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
1 Year
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
Must have an EDSS score between 0.0 and 5.0.
Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Key Exclusion Criteria:
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women
Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Periods
Title
Milestones
Reasons Not Completed
Year 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Peginterferon Beta-1a Q4W
Placebo
PEG IFN ß-1a
PEGylated interferon beta-1a
Plegridy
Placebo
Drug
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Peginterferon Beta-1a Q4W
Placebo
Proportion of Participants Relapsed at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
Year 1
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year
Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
1 Year
Ponte Vedra Beach
Florida
32082 4040
United States
Research Site
Atlanta
Georgia
30327
United States
Research Site
Des Moines
Iowa
50314
United States
Research Site
Lexington
Kentucky
40513
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Baltimore
Maryland
21287
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Teaneck
New Jersey
07666
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Raleigh
North Carolina
27607 6520
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Akron
Ohio
44320
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Cleveland
Ohio
44195
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Franklin
Tennessee
37064
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Round Rock
Texas
78681
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Brussels
1200
Belgium
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Sint-Truiden
3800
Belgium
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Plovdiv
4002
Bulgaria
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Sofia
1113
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Sofia
1309
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Sofia
1407
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Sofia
1431
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Sofia
1527
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Sofia
1606
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London
Ontario
N6A 5A5
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Montreal
Quebec
H2L4M1
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Santiago
8207257
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Bogota
Cundinamarca
Colombia
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Bogotá
Colombia
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Osijek
31000
Croatia
Research Site
Zagreb
10000
Croatia
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Brno
62500
Czechia
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Olomouc
77520
Czechia
Research Site
Ostrava
70852
Czechia
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Ostrava - Vitkovice
70200
Czechia
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Ostrava-Poruba
70300
Czechia
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Prague
12808
Czechia
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Prague
15006
Czechia
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Teplice
41529
Czechia
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Pärnu
EE 80010
Estonia
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Tallinn
EE 10617
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Tartu
EE 51014
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Amiens
80054
France
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Clermont-Ferrand
63003
France
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Lyon
69394
France
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Marseille
13385
France
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Nice
6002
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Tbilisi
112
Georgia
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Tbilisi
141
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Tbilisi
179
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Tbilisi
186
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Bayreuth
95445
Germany
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Berlin
10713
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Berlin
14163
Germany
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44791
Germany
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Cologne
50935
Germany
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64711
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91054
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Hamburg
20099
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Hanover
30559
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04103
Germany
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Marburg
35043
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80331
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Münster
48149
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Prien am Chiemsee
83209
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89079
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Westerstede
26655
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11521
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Athens
11525
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57010
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380006
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360001
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560043
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400026
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422004
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411004
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411030
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National Capital Territory of Delhi
110029
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New Delhi
National Capital Territory of Delhi
110060
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Saket
National Capital Territory of Delhi
110017
India
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Amritsar
Punjab
143001
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Jaipur
Rajasthan
302004
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Chennai
Tamil Nadu
600017
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Coimbatore
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641014
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West Bengal
700068
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560017
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575018
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400703
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Nehru Nagar
110065
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Riga
LV 1005
Latvia
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20127
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Chihuahua City
31203
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Mexico City
03310
Mexico
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Mexico City
10700
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Monterrey, Nuevo Leon
64710
Mexico
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Tijuana, Baja California
22320
Mexico
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Breda
4818CK
Netherlands
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Nieuwegein
3435CM
Netherlands
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Auckland
1023
New Zealand
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Christchurch
New Zealand
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New Zealand
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Lima
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Lima 27
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Bialystok
15276
Poland
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Bialystok
15402
Poland
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Bydgoszcz
85681
Poland
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Gdansk
80299
Poland
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Gdansk
80803
Poland
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Gdansk
80952
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26200
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Katowice
40650
Poland
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Katowice
40662
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40684
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Krakow
31505
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Krakow
31637
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Krakow
31826
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Lodz
90153
Poland
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Lublin
20718
Poland
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Lublin
20954
Poland
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Olsztyn
10082
Poland
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Plewiska
62064
Poland
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Poznan
60355
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Poznan
61853
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Szczecin
70215
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Szczecin
71252
Poland
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Warsaw
00851
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02957
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Warsaw
04141
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Warsaw
04749
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Wroclaw
50556
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41800
Poland
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500123
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50098
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115100
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Iași
700656
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Sibiu
550166
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540136
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454136
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Kaluga
248007
Russia
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420021
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350012
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Kursk
305007
Russia
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107150
Russia
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119021
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125367
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Moscow
127018
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630007
Russia
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Perm
614990
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Rostov-on-Don
344015
Russia
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Smolensk
214018
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Tomsk
634050
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Ufa
450005
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Belgrade
11000
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34000
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18000
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14008
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28041
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28046
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29010
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41071
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58018
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Dnipropetrovsk
49027
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83099
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Kharkiv
61068
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Kharkiv
61103
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Kyiv
3110
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Kyiv
4107
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Odesa
65025
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26011
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Simferopol
95017
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Ternopil
46027
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Vinnytsia
21005
Ukraine
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London
E1 1BB
United Kingdom
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Nottingham
NG7 2UH
United Kingdom
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Salford
M6 8HD
United Kingdom
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Sheffield
S10 2JF
United Kingdom
Derived
Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
Calabresi PA, Arnold DL, Sangurdekar D, Singh CM, Altincatal A, de Moor C, Engle B, Goyal J, Deykin A, Szak S, Kieseier BC, Rudick RA, Plavina T. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021 Sep;27(10):1497-1505. doi: 10.1177/1352458520972573. Epub 2020 Dec 14.
Cleanthous S, Cano S, Kinter E, Marquis P, Petrillo J, You X, Wakeford C, Sabatella G. Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT). Mult Scler J Exp Transl Clin. 2017 Aug 15;3(3):2055217317725917. doi: 10.1177/2055217317725917. eCollection 2017 Jul-Sep.
Scott TF, Kieseier BC, Newsome SD, Arnold DL, You X, Hung S, Sperling B. Improvement in relapse recovery with peginterferon beta-1a in patients with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316676644. doi: 10.1177/2055217316676644. eCollection 2016 Jan-Dec.
Arnold DL, Calabresi PA, Kieseier BC, Liu S, You X, Fiore D, Hung S. Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial. BMC Neurol. 2017 Feb 10;17(1):29. doi: 10.1186/s12883-017-0799-0.
Newsome SD, Guo S, Altincatal A, Proskorovsky I, Kinter E, Phillips G, You X, Sabatella G. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.
Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S. Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis. BMC Neurol. 2014 Dec 31;14:240. doi: 10.1186/s12883-014-0240-x.
Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S. Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study. Br J Clin Pharmacol. 2015 Mar;79(3):514-22. doi: 10.1111/bcp.12521.
FG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
FG003
Year 2: Placebo Followed by Peginterferon Beta-1a Q4W
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
FG004
Year 2: Placebo Followed by Peginterferon Beta-1a Q2W
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
FG005
Year 2: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
FG006
Year 2: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
FG000500 subjects
FG001501 subjects
FG002515 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Completed Year 1 Study Treatment
FG000456 subjects
FG001438 subjects
FG002438 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000456 subjects
FG001438 subjects
FG002439 subjects1 participant discontinued treatment before end of study period but remained to complete follow-up.
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00044 subjects
FG00163 subjects
FG00276 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Randomized But Not Treated
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Adverse Event
FG0004 subjects
FG00122 subjects
FG00224 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00030 subjects
FG00132 subjects
FG00236 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0004 subjects
FG0012 subjects
FG0027 subjects
FG0030 subjects
FG004
Year 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003228 subjects
FG004228 subjects
FG005438 subjects
FG006438 subjects
Completed Year 2 Study Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003200 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003198 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00330 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Intent-to-treat population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo every 2 weeks for 48 weeks
BG001
Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
BG002
Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000500
BG001500
BG002512
BG0031512
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.3± 9.74
BG00136.4± 9.87
BG00236.9± 9.79
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000358
BG001352
BG002
Expanded Disability Status Scale (EDSS)
The EDSS measures the disability status of people with multiple sclerosis (MS) on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic exam), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Title
Measurements
BG0002.44± 1.180
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Annualized Relapse Rate (ARR) at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).
Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).
Posted
Number
95% Confidence Interval
relapses per person-years
1 Year
ID
Title
Description
OG000
Year 1: Placebo
Placebo every 2 weeks for 48 weeks
OG001
Year 1: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
OG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Units
Counts
Participants
OG000500
OG001500
OG002512
Title
Denominators
Categories
Title
Measurements
OG0000.397(0.328 to 0.481)
OG0010.288(0.234 to 0.355)
OG0020.256(0.206 to 0.318)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Negative Binomial Regression
Based on negative binomial regression, with adjustment for baseline EDSS (< 4 versus ≥ 4), baseline relapse rate, age (< 40 versus ≥ 40 years).
0.0114
Rate Ratio
0.725
2-Sided
95
0.565
0.930
No
Superiority or Other
OG000
OG002
Secondary
Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year
Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.
ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.
Posted
Mean
95% Confidence Interval
lesions
1 Year
ID
Title
Description
OG000
Year 1: Placebo
Placebo every 2 weeks for 48 weeks
OG001
Year 1: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
OG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Secondary
Proportion of Participants Relapsed at 1 Year
A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.
ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.
Posted
Number
proportion of participants
Year 1
ID
Title
Description
OG000
Year 1: Placebo
Placebo every 2 weeks for 48 weeks
OG001
Year 1: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
OG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Secondary
Estimated Proportion of Participants With Sustained Disability Progression at 1 Year
Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.
ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.
Posted
Number
proportion of participants
1 Year
ID
Title
Description
OG000
Year 1: Placebo
Placebo every 2 weeks for 48 weeks
OG001
Year 1: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Time Frame
Screening through Week 96 (treatment period), plus 4 weeks (±5 days) follow-up
Description
One participant, randomized to placebo->Q4W, received one wrong dosing kit during Year 1, and was mistakenly distributed with one Q2W kit, therefore receiving study drug in Weeks 20 and 22 instead of placebo. For Year 1 safety tables, this participant was grouped with Q2W, and for Year 2 safety tables, this participant was grouped with Q4W.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Year 1: Placebo
Placebo every 2 weeks for 48 weeks
76
499
378
499
EG001
Year 1: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
70
500
466
500
EG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
55
513
472
513
EG003
Year 2: Placebo Followed by Peginterferon Beta-1a Q4W
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
42
227
190
227
EG004
Year 2: Placebo Followed by Peginterferon Beta-1a Q2W
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
36
228
206
228
EG005
Year 2: Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
67
439
373
439
EG006
Year 2: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
39
438
367
438
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dengue Fever
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0021 affected513 at risk
EG0030 affected227 at risk
EG0040 affected228 at risk
EG0050 affected439 at risk
EG0060 affected438 at risk
Pneumonia
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0012 affected500 at risk
EG0020 affected513 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0012 affected500 at risk
EG0020 affected513 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Sepsis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Septic Shock
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cervicitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Benign Vulval Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Cervix Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Depression
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Personality Disorder
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Conversion Disorder
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Multiple Sclerosis Relapse
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG00057 affected499 at risk
EG00147 affected500 at risk
EG00234 affected513 at risk
EG003
Multiple Sclerosis
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0021 affected513 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Cerebrovascular Insufficiency
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Neuritis Cranial
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Neuromyelitis Optica
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Partial Seizures
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Partial Seizures With Secondary Generalization
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Uhthoff's Phenomenon
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Subarachnoid Haemorrhage
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Venous Thrombosis Limb
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Acute Hepatic Failure
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Bile Duct Stone
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Intervertebral Disc Disorder
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0021 affected513 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Patellofemoral Pain Syndrome
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Micturition Disorder
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Abortion Incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Endometrial Hyperplasia
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Death
General disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Injection Site Reaction
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Irritability
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Chest Pain
General disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Gait Disturbance
General disorders
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Transaminases Increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0021 affected513 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0011 affected500 at risk
EG0020 affected513 at risk
EG003
Avulsion Fracture
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Meniscus Lesion
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0001 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cystitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Infected Skin Ulcer
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Bacterial Diarrhoea
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cellulitis Gangrenous
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Chronic Sinusitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Endometritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Myometritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Pelvic Inflammatory Disease
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Pyelonephritis Chronic
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Salpingo-Oophoritis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Typhoid Fever
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Viral Pharyngitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Viral Tracheitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Lip And/Or Oral Cavity Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Basedow's Disease
Endocrine disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Bulbar Palsy
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Complex Partial Seizures
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Extrapyramidal Disorder
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Grand Mal Convulsion
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Syncope
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Trigeminal Neuralgia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cardiopulmonary Failure
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Shock
Vascular disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Organising Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Intestinal Strangulation
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Hepatic Function Abnormal
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Hepatitis Toxic
Hepatobiliary disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Enthesopathy
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Sacroilitis
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Cervical Dysplasia
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Ectropion Of Cervix
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Epididymal Cyst
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Pelvic Adhesions
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Uterine Cervical Erosion
Reproductive system and breast disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Congenital Cystic Kidney Disease
Congenital, familial and genetic disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Hyperpyrexia
General disorders
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA (15.0)
Systematic Assessment
EG0000 affected499 at risk
EG0010 affected500 at risk
EG0020 affected513 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG00077 affected499 at risk
EG00169 affected500 at risk
EG00254 affected513 at risk
EG00322 affected227 at risk
EG00417 affected228 at risk
EG00545 affected439 at risk
EG00647 affected438 at risk
Urinary Tract Infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG00020 affected499 at risk
EG00128 affected500 at risk
EG00228 affected513 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (15.0)
Systematic Assessment
EG00027 affected499 at risk
EG00116 affected500 at risk
EG00228 affected513 at risk
EG003
Depression
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG00021 affected499 at risk
EG00125 affected500 at risk
EG00222 affected513 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (15.0)
Systematic Assessment
EG00019 affected499 at risk
EG00118 affected500 at risk
EG00228 affected513 at risk
EG003
Headache
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG000165 affected499 at risk
EG001206 affected500 at risk
EG002225 affected513 at risk
EG003
Multiple Sclerosis Relapse
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG000154 affected499 at risk
EG001111 affected500 at risk
EG00290 affected513 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG00030 affected499 at risk
EG00122 affected500 at risk
EG00235 affected513 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG00023 affected499 at risk
EG00122 affected500 at risk
EG00226 affected513 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (15.0)
Systematic Assessment
EG00030 affected499 at risk
EG00129 affected500 at risk
EG00217 affected513 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (15.0)
Systematic Assessment
EG00043 affected499 at risk
EG00132 affected500 at risk
EG00227 affected513 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG00031 affected499 at risk
EG00126 affected500 at risk
EG00234 affected513 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (15.0)
Systematic Assessment
EG00028 affected499 at risk
EG00126 affected500 at risk
EG00221 affected513 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG00031 affected499 at risk
EG00143 affected500 at risk
EG00245 affected513 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG00011 affected499 at risk
EG00137 affected500 at risk
EG00226 affected513 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (15.0)
Systematic Assessment
EG00023 affected499 at risk
EG00122 affected500 at risk
EG00218 affected513 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG00030 affected499 at risk
EG00197 affected500 at risk
EG00299 affected513 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG00057 affected499 at risk
EG00164 affected500 at risk
EG00262 affected513 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG00035 affected499 at risk
EG00154 affected500 at risk
EG00258 affected513 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG00048 affected499 at risk
EG00153 affected500 at risk
EG00244 affected513 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (15.0)
Systematic Assessment
EG00018 affected499 at risk
EG00123 affected500 at risk
EG00222 affected513 at risk
EG003
Injection Site Erythema
General disorders
MedDRA (15.0)
Systematic Assessment
EG00033 affected499 at risk
EG001282 affected500 at risk
EG002315 affected513 at risk
EG003
Influenza Like Illness
General disorders
MedDRA (15.0)
Systematic Assessment
EG00063 affected499 at risk
EG001234 affected500 at risk
EG002238 affected513 at risk
EG003
Pyrexia
General disorders
MedDRA (15.0)
Systematic Assessment
EG00075 affected499 at risk
EG001218 affected500 at risk
EG002227 affected513 at risk
EG003
Chills
General disorders
MedDRA (15.0)
Systematic Assessment
EG00023 affected499 at risk
EG00192 affected500 at risk
EG00288 affected513 at risk
EG003
Injection Site Pain
General disorders
MedDRA (15.0)
Systematic Assessment
EG00015 affected499 at risk
EG00167 affected500 at risk
EG00278 affected513 at risk
EG003
Asthenia
General disorders
MedDRA (15.0)
Systematic Assessment
EG00038 affected499 at risk
EG00170 affected500 at risk
EG00268 affected513 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA (15.0)
Systematic Assessment
EG0006 affected499 at risk
EG00156 affected500 at risk
EG00270 affected513 at risk
EG003
Fatigue
General disorders
MedDRA (15.0)
Systematic Assessment
EG00049 affected499 at risk
EG00155 affected500 at risk
EG00252 affected513 at risk
EG003
Pain
General disorders
MedDRA (15.0)
Systematic Assessment
EG00016 affected499 at risk
EG00129 affected500 at risk
EG00225 affected513 at risk
EG003
Hyperthermia
General disorders
MedDRA (15.0)
Systematic Assessment
EG0005 affected499 at risk
EG00126 affected500 at risk
EG00222 affected513 at risk
EG003
Body Temperature Increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG00014 affected499 at risk
EG00133 affected500 at risk
EG00231 affected513 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA (15.0)
Systematic Assessment
EG00013 affected499 at risk
EG00119 affected500 at risk
EG00229 affected513 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Biogen Idec Study Medical Director
Biogen Idec
clinicaltrials@biogenidec.com
ID
Term
D012008
Recurrence
D009103
Multiple Sclerosis
Ancestor Terms
ID
Term
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C428112
peginterferon beta-1a
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
196 subjects
FG005391 subjects
FG006411 subjects
193 subjects
FG005391 subjects
FG006409 subjects
35 subjects
FG00547 subjects
FG00629 subjects
9 subjects
FG0048 subjects
FG00511 subjects
FG0066 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0044 subjects
FG0052 subjects
FG0064 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00317 subjects
FG00418 subjects
FG00527 subjects
FG00613 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0056 subjects
FG0063 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
36.5
± 9.80
361
BG0031071
Male
BG000142
BG001148
BG002151
BG003441
2.48
± 1.244
BG0022.47± 1.255
BG0032.46± 1.226
Negative Binomial Regression
Based on negative binomial regression, with adjustment for baseline EDSS (< 4 versus ≥ 4), baseline relapse rate, age (< 40 versus ≥ 40).
0.0007
Rate Ratio
0.644
2-Sided
95
0.500
0.831
No
Superiority or Other
Units
Counts
Participants
OG000476
OG001462
OG002457
Title
Denominators
Categories
Title
Measurements
OG00010.9± 19.51(9.6 to 12.5)
OG0017.9± 15.84(6.9 to 9.0)
OG0023.6± 8.55(3.1 to 4.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Negative Binomial Regression
Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.
0.0008
Lesion Mean Ratio
0.72
2-Sided
95
0.60
0.87
No
Superiority or Other
OG000
OG002
Negative Binomial Regression
Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.
<0.0001
Lesion Mean Ratio
0.33
2-Sided
95
0.27
0.40
No
Superiority or Other
Units
Counts
Participants
OG000500
OG001500
OG002512
Title
Denominators
Categories
Title
Measurements
OG0000.291
OG0010.222
OG0020.187
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportion Hazards model
0.0200
Based on Cox proportion hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4), age (<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).
Hazard Ratio (HR)
0.74
2-Sided
95
0.57
0.95
No
Superiority or Other
OG000
OG002
Cox Proportion Hazards model
0.0003
Based on Cox proportion hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4), age (<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).
Hazard Ratio (HR)
0.61
2-Sided
95
0.47
0.80
No
Superiority or Other
OG002
Year 1: Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
Units
Counts
Participants
OG000500
OG001500
OG002512
Title
Denominators
Categories
Title
Measurements
OG0000.105
OG0010.068
OG0020.068
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportion Hazards model
0.0380
Based on Cox Proportional Hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4) and age (< 40 versus ≥ 40 years).
Hazard Ratio (HR)
0.62
2-Sided
95
0.40
0.97
No
Superiority or Other
OG000
OG002
Cox Proportion Hazards model
0.0383
Based on Cox Proportional Hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4) and age (< 40 versus ≥ 40 years).