A Study of the Efficacy and Safety of Ocrelizumab in Pati... | NCT00676715 | Trialant
NCT00676715
Sponsor
Genentech, Inc.
Status
Completed
Last Update Posted
Dec 31, 2024Actual
Enrollment
220Actual
Phase
Phase 2
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
Placebo
Ocrelizumab
Avonex
Countries
United States
Belgium
Bulgaria
Canada
Czechia
Denmark
France
Germany
Italy
Mexico
Romania
Russia
Serbia
Slovakia
Spain
Switzerland
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00676715
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACT4422g
Secondary IDs
ID
Type
Description
Link
2007-006338-32
EudraCT Number
WA21493
Other Identifier
Hoffmann-La Roche
Brief Title
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title
Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
Acronym
Not provided
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2024
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
Jul 17, 2008Actual
Primary Completion Date
Mar 9, 2012Actual
Completion Date
Nov 8, 2023Actual
First Submitted Date
May 9, 2008
First Submission Date that Met QC Criteria
May 9, 2008
First Posted Date
May 13, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2017
Results First Submitted that Met QC Criteria
Mar 31, 2017
Results First Posted Date
May 11, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 25, 2013
Certification/Extension First Submitted that Passed QC Review
Mar 25, 2013
Certification/Extension First Posted Date
Apr 1, 2013Estimated
Last Update Submitted Date
Dec 9, 2024
Last Update Posted Date
Dec 31, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Name
Class
Roche Pharma AG
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Sclerosis, Relapsing-Remitting
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
220Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
Drug: Placebo
Ocrelizumab 600 mg
Experimental
Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Drug: Ocrelizumab
Ocrelizumab 1000 mg
Experimental
Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
Drug: Ocrelizumab
Avonex
Active Comparator
Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
Week 12 to Week 24
Secondary Outcomes
Measure
Description
Time Frame
Annualized Protocol Defined Relapse Rate at Week 24
Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.
Week 24
Percentage of Participants Who Remained Relapse Free at Week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Relapsing-remitting multiple sclerosis (MS)
Ages 18-55 years inclusive
For sexually active female and male participants of reproductive potential, use of reliable means of contraception
Exclusion Criteria:
Secondary or primary progressive multiple sclerosis at screening
Incompatibility with MRI
Contra-indications to or intolerance of oral or IV corticosteroids
Known presence of other neurologic disorders
Pregnancy or lactation
Lack of peripheral venous access
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
Congestive heart failure
Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
History or known presence of recurrent or chronic infection
History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
History of alcohol or drug abuse within 24 weeks prior to randomization
History of or currently active primary or secondary immunodeficiency
History of coagulation disorders
Treatment with any investigational agent within 4 weeks of screening
Receipt of a live vaccine within 6 weeks prior to randomization
Incompatibility with Avonex use
Previous treatment with rituximab
Previous treatment with lymphocyte-depleting therapies except mitoxantrone
Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
Systemic corticosteroid therapy within 4 weeks prior to randomization
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a 96-week Treatment Period (TP) followed by a Treatment-free period (TFP). Participants who completed both TP & TFP (at least Week 120) were invited to participate in the optional Open-label Extension (OLE) period.
Recruitment Details
A total of 220 participants were randomized, of which 218 received study treatment. Participants took part in the study at 79 investigative sites across 18 countries from July 17, 2008, to November 08, 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as, intravenous (IV) infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 milligrams (mg), IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, every 24 weeks (Q24W).
Periods
Title
Milestones
Reasons Not Completed
Treatment Period (TP)
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
Finland
Netherlands
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
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Avonex
Ocrelizumab
Drug
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
Ocrelizumab 1000 mg
Ocrelizumab 600 mg
RO4964913
Avonex
Drug
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
Avonex
Interferon-beta-alpha1
Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.
Week 24
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.
Baseline, Week 24
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
Weeks 4 to Week 24
Total Number of Gadolinium-Enhancing T1 Lesions
Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.
Weeks 4 to Week 24
Phoenix
Arizona
85013
United States
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley
California
94705
United States
University of California San Francisco
San Francisco
California
94117
United States
Advanced Neurology of Colorado, LLC
Fort Collins
Colorado
80528
United States
Bradenton Research Center
Bradenton
Florida
34205
United States
MS Center of Vero Beach
Vero Beach
Florida
32960
United States
Shepherd Center; Multiple Sclerosis Center
Atlanta
Georgia
30309
United States
University of Chicago; Neurology
Chicago
Illinois
60637
United States
Kansas University Medical Center
Kansas City
Kansas
66103
United States
John Hopkins University
Baltimore
Maryland
21205
United States
Michigan Institute for Neurological Disorders
Farmington Hills
Michigan
48334
United States
Dartmouth-Hitchcock Medical Center; Dept of Neurology
Lebanon
New Hampshire
03756
United States
Columbia University Medical Center; The Neurological Institute of New York
New York
New York
10032
United States
Island Neurological Associates, P.C.
Plainview
New York
11803
United States
Suny At Stony Brook; Department Of Neurology
Stony Brook
New York
11794
United States
The Neurological Institute PA
Charlotte
North Carolina
28204
United States
Clinical Research of Winston Salem
Winston-Salem
North Carolina
27103
United States
Cleveland Clinic
Cleveland
Ohio
44106
United States
Ohio State University Med Ctr; MS Center
Columbus
Ohio
43221
United States
Legacy Health System; Clinical Research & Tech Ctr
Tualatin
Oregon
97062
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37212
United States
Baylor College of Medicine
Houston
Texas
77030
United States
Integra Clinical Research, Llc
San Antonio
Texas
78229
United States
Fletcher Allen Health Care/University of Vermont
Burlington
Vermont
5405
United States
University of Virginia - Fontain Research Park
Charlottesville
Virginia
22903
United States
UZ Antwerpen
Edegem
2650
Belgium
First MHAT; Clinic of Neurology
Sofia
1000
Bulgaria
Shat of Cardiovascular Diseases; Clinic of Neurology
Sofia
1309
Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia
1407
Bulgaria
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
Sofia
1527
Bulgaria
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
Sofia
1606
Bulgaria
Military Medical Academy; Neurology
Sofia
1606
Bulgaria
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver
British Columbia
V6T 2B5
Canada
St. Michael'S Hospital
Toronto
Ontario
M5B 1W8
Canada
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal
Quebec
H3A 2B4
Canada
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava
708 52
Czechia
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice
532 03
Czechia
Fakultni nemocnice Motol; Neurologicka klinika
Prague
150 06
Czechia
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
Marburg
35039
Germany
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
Rome
Lazio
00189
Italy
Hospital CIMA, Sta. Engracia
Monterrey
Nuevo León
64060
Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes
20127
Mexico
Unidad de Investigacion CIMA SC
Chihuahua City
31200
Mexico
Hospital Cima Chihauhau
Chihuahua City
31328
Mexico
Spitalul Clinic Colentina; Clinica de Neurologie
Bucharest
020125
Romania
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Târgu Mureş
540136
Romania
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva
Moscow Oblast
107150
Russia
Municipal City Hospital #33; Neurology
Nizhny Novgorod
Niznij Novgorod
603076
Russia
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Yekaterinburg
Sverdlovsk Oblast
620102
Russia
LLC Research Medical Complex Vashe Zdorovie
Kazan'
Tatarstan Republic
4420029
Russia
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen
Tyumen Oblast
625048
Russia
MRC for Oncology and Neurology; Neurology
Novosibirsk
630090
Russia
Clinical Center of Serbia; Institute of Neurology
Belgrade
11000
Serbia
Clinical Center Nis; Clinic for Mental Health
Niš
18000
Serbia
Clinic of Neurology
Nova Sad
21000
Serbia
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
Banská Bystrica
975 17
Slovakia
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
Bratislava
813 69
Slovakia
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
Košice
041 66
Slovakia
Fakultna Nemocnica Nitra; Neurologicka Klinika
Nitra
949 01
Slovakia
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
Spišská Nová Ves
05201
Slovakia
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona
08035
Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona
08036
Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid
28034
Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Málaga
29010
Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville
41009
Spain
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia
46026
Spain
Universitätsspital Basel; Neurologie
Basel
4031
Switzerland
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkiv
61068
Ukraine
City Clin.Hosp #4; Dept. of Neurology
Kyiv
03110
Ukraine
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
Propetrovsk
49027
Ukraine
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsia
21005
Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool
L9 7LJ
United Kingdom
Uni Hospital Queens Medical Centre; Neurology
Nottingham
NG7 2UH
United Kingdom
Royal Hallamshire Hospital; Neurology
Sheffield
S10 2JF
United Kingdom
FG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
FG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
FG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 micrograms (mcg) as intramuscular (IM) injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
FG00054 subjects
FG00155 subjects
FG00255 subjects
FG00354 subjects
COMPLETED
FG00048 subjects
FG00146 subjects
FG00243 subjects
FG00346 subjects
NOT COMPLETED
FG0006 subjects
FG0019 subjects
FG00212 subjects
FG0038 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Failure to return
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Violation of selection criteria at entry
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Refused treatment/did not cooperate
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
Withdrew consent
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
Insufficient therapeutic response
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
Administrative
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Treatment-free Period (TFP)
Type
Comment
Milestone Data
STARTED
FG00049 subjectsParticipants who completed TP or withdrew from ocrelizumab entered the TFP.
FG00148 subjectsParticipants who completed TP or withdrew from ocrelizumab entered the TFP.
FG00250 subjectsParticipants who completed TP or withdrew from ocrelizumab entered the TFP.
FG00349 subjectsParticipants who completed TP or withdrew from ocrelizumab entered the TFP.
COMPLETED
FG00035 subjects
FG00132 subjects
FG00230 subjects
FG00335 subjects
NOT COMPLETED
FG00014 subjects
FG00116 subjects
FG00220 subjects
FG00314 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG003
Open Label Extension (OLE)
Type
Comment
Milestone Data
STARTED
FG00029 subjects
FG00132 subjects
FG00219 subjects
FG00324 subjects
COMPLETED
FG00022 subjects
FG00121 subjects
FG00211 subjects
FG00314 subjects
NOT COMPLETED
FG0007 subjects
FG00111 subjects
FG0028 subjects
FG00310 subjects
Type
Comment
Reasons
Reason not provided
FG0003 subjects
FG0014 subjects
FG0021 subjects
FG003
The safety population included all participants who received any study drug and underwent at least one assessment of safety.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
BG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
BG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
BG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00054
BG00155
BG00255
BG00354
BG004218
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
BG00038.0± 8.8
BG00135.6± 8.5
BG00238.5± 8.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG00135
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
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
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
The intent-to-treat population includes all randomized participants who had received any study drug. Overall number of participants analyzed is the number of participants with data available for analyses.
Posted
Mean
Standard Deviation
lesions
Week 12 to Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Units
Counts
Participants
OG00054
OG00151
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.6± 12.53
OG0010.6± 1.52
OG0020.2± 0.65
OG003
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
Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).
Van Elteren Test (stratified)
<0.0001
Superiority or Other (legacy)
OG000
OG002
Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).
Secondary
Annualized Protocol Defined Relapse Rate at Week 24
Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.
The intent-to-treat population includes all randomized participants who had received any study drug.
Posted
Number
95% Confidence Interval
relapses per year
Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Secondary
Percentage of Participants Who Remained Relapse Free at Week 24
Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.
The intent-to-treat population includes all randomized participants who had received any study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Secondary
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.
The intent-to-treat population includes all randomized participants who had received any study drug. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints.
Posted
Mean
Standard Deviation
cubic millimeter (mm^3)
Baseline, Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Secondary
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
The intent-to-treat population includes all randomized participants who had received any study drug. Overall number of participants analyzed is the number of participants with data available for analyses.
Posted
Mean
Standard Deviation
lesions
Weeks 4 to Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Secondary
Total Number of Gadolinium-Enhancing T1 Lesions
Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.
The intent-to-treat population includes all randomized participants who had received any study drug. Overall number of participants analyzed is the number of participants with data available for analyses.
Posted
Mean
Standard Deviation
lesions
Weeks 4 to Week 24
ID
Title
Description
OG000
Placebo / Ocrelizumab 600 mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG001
Ocrelizumab 600 mg / Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Time Frame
Up to 787 Weeks
Description
The safety population included all participants who received any study drug and underwent at least one assessment of safety. As per planned analysis adverse events from both the TP and TFP were combined and reported as participants received no interventions during the TFP. As prespecified in the protocol AEs were collected as per planned arm groups irrespective of intervention or dose level and are thus reported accordingly.
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
Placebo/Ocrelizumab 600mg
In the Treatment Period, participants received placebo as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.
3
54
11
54
52
54
EG001
Ocrelizumab 600mg/Ocrelizumab 600mg
In the Treatment Period, participants received ocrelizumab 300 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 600 mg, IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W
1
55
17
55
47
55
EG002
Ocrelizumab 1000mg/Ocrelizumab 600mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.
3
55
16
55
45
55
EG003
Avonex/Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection once every week of Cycle 1 (1 Cycle = 168 days), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600mg, Q24W.
2
54
16
54
45
54
EG004
Ocrelizumab 600 mg Open Label Extension (OLE)
Participants who opted to enroll in the OLE received two IV infusions of ocrelizumab, 300mg on Days 1 and 15 of Cycle 5, followed by a single infusion of ocrelizumab, 600mg, once Q24W
6
103
28
103
85
103
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG0030 events0 affected54 at risk
EG0041 events1 affected103 at risk
IMMUNE THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
CARDIAC ARREST
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ADRENAL CYST
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
RETINAL ARTERY OCCLUSION
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
COLITIS
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
INGUINAL HERNIA STRANGULATED
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
LARGE INTESTINE POLYP
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SALIVARY DUCT INFLAMMATION
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SUBILEUS
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
DEATH
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
DRUG WITHDRAWAL SYNDROME
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
PYREXIA
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0022 events1 affected55 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
CHOLECYSTITIS CHRONIC
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ANAL ABSCESS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
COMPLICATED APPENDICITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0013 events3 affected55 at risk
EG0020 events0 affected55 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ENCEPHALITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
GINGIVITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
HEPATITIS A
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0011 events1 affected55 at risk
EG0021 events1 affected55 at risk
EG003
PYELONEPHRITIS ACUTE
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
TRACHEOBRONCHITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0025 events3 affected55 at risk
EG003
UROSEPSIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
INJURY
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
AMYLASE INCREASED
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SMEAR CERVIX ABNORMAL
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0011 events1 affected55 at risk
EG0021 events1 affected55 at risk
EG003
RHEUMATOID ARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ROTATOR CUFF SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
LUNG NEOPLASM MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SQUAMOUS CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
EPILEPSY
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
MULTIPLE SCLEROSIS PSEUDO RELAPSE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
MULTIPLE SCLEROSIS RELAPSE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
MUSCLE SPASTICITY
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
NERVOUS SYSTEM DISORDER
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
PREGNANCY
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ACUTE PSYCHOSIS
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SUSPECTED SUICIDE ATTEMPT
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
URETEROLITHIASIS
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
OVARIAN MASS
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
UTERINE PROLAPSE
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ERYTHEMA NODOSUM
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0002 events1 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0013 events3 affected55 at risk
EG0020 events0 affected55 at risk
EG0030 events0 affected54 at risk
EG0042 events2 affected103 at risk
PALPITATIONS
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0011 events1 affected55 at risk
EG0023 events3 affected55 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events2 affected55 at risk
EG0023 events3 affected55 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0013 events3 affected55 at risk
EG0024 events4 affected55 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0016 events4 affected55 at risk
EG0026 events5 affected55 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0022 events1 affected55 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events2 affected55 at risk
EG00210 events7 affected55 at risk
EG003
ASTHENIA
General disorders
MedDRA 26.1
Systematic Assessment
EG0005 events3 affected54 at risk
EG0012 events2 affected55 at risk
EG0023 events2 affected55 at risk
EG003
CHILLS
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0012 events2 affected55 at risk
EG0021 events1 affected55 at risk
EG003
FATIGUE
General disorders
MedDRA 26.1
Systematic Assessment
EG0008 events5 affected54 at risk
EG0017 events7 affected55 at risk
EG00214 events11 affected55 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0012 events2 affected55 at risk
EG0022 events2 affected55 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
PYREXIA
General disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0018 events8 affected55 at risk
EG0024 events3 affected55 at risk
EG003
HYPOGAMMAGLOBULINAEMIA
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected55 at risk
EG0020 events0 affected55 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0011 events1 affected55 at risk
EG0023 events3 affected55 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00012 events7 affected54 at risk
EG0014 events4 affected55 at risk
EG00211 events6 affected55 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00013 events12 affected54 at risk
EG0018 events7 affected55 at risk
EG0025 events5 affected55 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0005 events4 affected54 at risk
EG0014 events2 affected55 at risk
EG0026 events5 affected55 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected55 at risk
EG0022 events2 affected55 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0017 events5 affected55 at risk
EG0021 events1 affected55 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected55 at risk
EG0021 events1 affected55 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0008 events7 affected54 at risk
EG0014 events4 affected55 at risk
EG00211 events7 affected55 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00015 events10 affected54 at risk
EG00132 events15 affected55 at risk
EG00225 events12 affected55 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00017 events4 affected54 at risk
EG0017 events3 affected55 at risk
EG0023 events2 affected55 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0007 events6 affected54 at risk
EG0016 events3 affected55 at risk
EG0021 events1 affected55 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0005 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0024 events3 affected55 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00018 events8 affected54 at risk
EG0018 events5 affected55 at risk
EG0025 events2 affected55 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0016 events3 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0007 events5 affected54 at risk
EG0014 events4 affected55 at risk
EG0024 events3 affected55 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00017 events10 affected54 at risk
EG00125 events14 affected55 at risk
EG00226 events11 affected55 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG00029 events14 affected54 at risk
EG00124 events10 affected55 at risk
EG00239 events15 affected55 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected55 at risk
EG0020 events0 affected55 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected55 at risk
EG0022 events2 affected55 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected54 at risk
EG0013 events3 affected55 at risk
EG0023 events3 affected55 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0011 events1 affected55 at risk
EG0023 events3 affected55 at risk
EG003
INFUSION RELATED REACTION
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG00063 events29 affected54 at risk
EG00160 events25 affected55 at risk
EG00260 events29 affected55 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0011 events1 affected55 at risk
EG0026 events5 affected55 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected55 at risk
EG0024 events4 affected55 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0023 events3 affected55 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0013 events3 affected55 at risk
EG0022 events2 affected55 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG00015 events8 affected54 at risk
EG00110 events9 affected55 at risk
EG0028 events5 affected55 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG00011 events9 affected54 at risk
EG0017 events5 affected55 at risk
EG0025 events4 affected55 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0015 events4 affected55 at risk
EG0024 events3 affected55 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected55 at risk
EG0022 events2 affected55 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG00011 events7 affected54 at risk
EG0012 events2 affected55 at risk
EG00210 events8 affected55 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0006 events5 affected54 at risk
EG0014 events4 affected55 at risk
EG0026 events4 affected55 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG00033 events15 affected54 at risk
EG00116 events9 affected55 at risk
EG00214 events10 affected55 at risk
EG003
HYPOAESTHESIA
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events2 affected55 at risk
EG0025 events5 affected55 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0006 events5 affected54 at risk
EG0016 events4 affected55 at risk
EG0022 events2 affected55 at risk
EG003
MULTIPLE SCLEROSIS RELAPSE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG00070 events26 affected54 at risk
EG00139 events19 affected55 at risk
EG00272 events21 affected55 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0014 events4 affected55 at risk
EG0025 events5 affected55 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0021 events1 affected55 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected54 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0017 events5 affected55 at risk
EG0023 events3 affected55 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0018 events7 affected55 at risk
EG0025 events5 affected55 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected54 at risk
EG0014 events3 affected55 at risk
EG00212 events9 affected55 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0015 events3 affected55 at risk
EG0021 events1 affected55 at risk
EG003
RENAL CYST
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0021 events1 affected55 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected55 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0015 events3 affected55 at risk
EG0023 events3 affected55 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected54 at risk
EG0011 events1 affected55 at risk
EG0023 events3 affected55 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0013 events3 affected55 at risk
EG0020 events0 affected55 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0014 events4 affected55 at risk
EG0022 events2 affected55 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0013 events2 affected55 at risk
EG0024 events4 affected55 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected54 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected55 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0004 events4 affected54 at risk
EG0017 events6 affected55 at risk
EG0020 events0 affected55 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800 821-8590
genentech@druginfo.com
ID
Term
D020529
Multiple Sclerosis, Relapsing-Remitting
Ancestor Terms
ID
Term
D009103
Multiple Sclerosis
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
C533411
ocrelizumab
D000068556
Interferon beta-1a
Ancestor Terms
ID
Term
D016899
Interferon-beta
D007370
Interferon Type I
D007372
Interferons
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D011506
Proteins
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
5 subjects
Reason not provided
FG0008 subjects
FG00110 subjects
FG0028 subjects
FG0037 subjects
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0026 subjects
FG0032 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
4 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0023 subjects
FG0033 subjects
Adverse Event
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
Death
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
38.1
± 9.3
BG00437.6± 8.8
38
BG00332
BG004141
Male
BG00018
BG00120
BG00217
BG00322
BG00477
7
BG0037
BG00426
Not Hispanic or Latino
BG00048
BG00149
BG00248
BG00347
BG004192
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
0
BG0030
BG0041
Asian
BG0001
BG0010
BG0020
BG0030
BG0041
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
Black or African American
BG0000
BG0013
BG0022
BG0031
BG0046
White
BG00052
BG00151
BG00253
BG00353
BG004209
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0001
BG0010
BG0020
BG0030
BG0041
52
6.9
± 16.01
Van Elteren Test (stratified)
<0.0001
Superiority or Other (legacy)
OG000
OG003
Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).
Van Elteren Test (stratified)
0.7496
Superiority or Other (legacy)
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Units
Counts
Participants
OG00054
OG00155
OG00255
OG00354
Title
Denominators
Categories
Title
Measurements
OG0000.557(0.370 to 0.839)
OG0010.127(0.054 to 0.299)
OG0020.213(0.110 to 0.414)
OG0030.364(0.220 to 0.602)
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
Poisson model was fitted for adjusting for geographic region only.
Poisson model
0.0019
Superiority or Other (legacy)
OG000
OG002
Poisson model was fitted for adjusting for geographic region only.
Poisson model
0.0136
Superiority or Other (legacy)
OG000
OG003
Poisson model was fitted for adjusting for geographic region only.
Poisson model
0.1814
Superiority or Other (legacy)
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Units
Counts
Participants
OG00054
OG00155
OG00255
OG00354
Title
Denominators
Categories
Title
Measurements
OG00075.9(64.5 to 87.3)
OG00185.5(76.1 to 94.8)
OG00287.3(78.5 to 96.1)
OG00377.8(66.7 to 88.9)
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
Cochran-Mantel-Haenszel chi-square test
Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.
0.1978
Relative risk (RR)
0.60
2-Sided
95
0.27
1.34
Superiority or Other (legacy)
OG000
OG002
CMH chi-square test
CMH chi-square test stratified by geographical region only.
0.1310
Relative risk (RR)
0.53
2-Sided
95
0.23
1.22
Superiority or Other (legacy)
OG000
OG003
CMH chi-square tes
CMH chi-square test stratified by geographical region only.
0.8206
Relative risk (RR)
0.92
2-Sided
95
0.46
1.84
Superiority or Other (legacy)
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Units
Counts
Participants
OG00047
OG00151
OG00253
OG00349
Title
Denominators
Categories
Baseline
ParticipantsOG00047
ParticipantsOG00151
ParticipantsOG00253
ParticipantsOG00349
Title
Measurements
OG0008950.84± 9776.261
OG00113972.61± 19930.158
OG00213178.30± 14271.383
OG003
Change at Week 24
ParticipantsOG00043
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00346
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
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
0.1391
Superiority or Other (legacy)
OG000
OG002
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
0.1596
Superiority or Other (legacy)
OG000
OG003
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
0.4740
Superiority or Other (legacy)
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
Units
Counts
Participants
OG00054
OG00151
OG00252
OG00352
Title
Denominators
Categories
Title
Measurements
OG0005.1± 11.99
OG0010.8± 1.95
OG0020.8± 2.16
OG0036.2± 13.79
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
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
<0.0001
Superiority or Other (legacy)
OG000
OG002
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
<0.0001
Superiority or Other (legacy)
OG000
OG003
Van Elteren Test (stratified)
Van Elteren test is stratified by region only.
0.4985
Superiority or Other (legacy)
OG002
Ocrelizumab 1000 mg/ Ocrelizumab 600 mg
In the Treatment Period, participants received ocrelizumab 1000 mg as IV infusion on Days 1 and 15 of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 1000 mg IV, on Day 1 and placebo IV on Day 15 of Cycle 2. Participants then received ocrelizumab, 1000 mg, IV, on Day 1 of Cycle 3 and ocrelizumab, 600 mg, IV, on Day 1 of Cycle 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.
OG003
Avonex / Ocrelizumab 600 mg
In the Treatment Period, participants received Avonex 30 mcg as IM injection every week of Cycle 1 ( 1 Cycle = 168 days ), followed by ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 2. Participants then received ocrelizumab, 600 mg, IV, on Day 1 of Cycles 3 and 4. Participants who completed the TP then entered the TFP which was of variable duration. Participants who completed the TP and the TFP (at least through Week 120) and opted to enroll in the OLE period received ocrelizumab, 300 mg, IV, on Days 1 and 15 of Cycle 5 followed by a single infusion of ocrelizumab, 600 mg, Q24W.