COMparison Between All immunoTherapies for Multiple Scler... | NCT03193866 | Trialant
NCT03193866
Sponsor
Karolinska Institutet
Status
Completed
Last Update Posted
Apr 20, 2025Actual
Enrollment
3,526Actual
Phase
Not provided
Conditions
Relapsing-remitting Multiple Sclerosis
Interventions
Rituximab
Countries
Sweden
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03193866
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
COMBAT-MS
Secondary IDs
Not provided
Brief Title
COMparison Between All immunoTherapies for Multiple Sclerosis.
Official Title
COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis
Acronym
COMBAT-MS
Organization
Karolinska InstitutetOTHER
Status Module
Record Verification Date
Mar 2025
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 2, 2017Actual
Primary Completion Date
Mar 31, 2022Actual
Completion Date
Mar 31, 2022Actual
First Submitted Date
Apr 20, 2017
First Submission Date that Met QC Criteria
Jun 18, 2017
First Posted Date
Jun 21, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2023
Results First Submitted that Met QC Criteria
Mar 31, 2025
Results First Posted Date
Apr 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 31, 2025
Last Update Posted Date
Apr 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Fredrik Piehl, Professor, Karolinska InstitutetPrincipal Investigator
Lead Sponsor
Karolinska InstitutetOTHER
Collaborators
Name
Class
Patient-Centered Outcomes Research Institute
OTHER
Kaiser Foundation Research Institute
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).
Detailed Description
This is a prospective non-intervention observational prospective cohort study assessing the long-term safety and efficacy of RTX treatment in MS compared with other common MS DMTs regarding both clinical and radiological parameters in a real-life population of patients with MS.
A number of parameters will be assessed annually. These include baseline demographics, previous drug history and reasons for discontinuation, disability status (expanded disability status scale), relapses, safety and adverse events (AE), contrast enhancing T1 and newly appearing T2 lesions on magnetic resonance imaging, as well as a panel of patient reported outcome measures: Symbol Digit Modalities Test (SDMT); MS impact scale-29 (MSIS-29) Fatigue Scale for Motor and Cognitive Functions (FSMC), EuroQol-5 Dimensions (EQ-5D), the MS check scale and Treatment Satisfaction Questionnaire 9 (TSQM-9).
Retrospective data entered in medical charts and the Swedish MS registry will be included together with prospective annual structured follow up from inclusion into the study for a minimum of three years (three to nine years).
In a substudy - Covid Enhancement study - analyses will be performed regarding the effect of COVID-19 on people with MS as compared to non-MS individuals and also if there is any indication that a particular DMD is associated with a risk to contract a more severe COVID-19. The analyses will primarily be performed in official health care databases.
Conditions Module
Conditions
Relapsing-remitting Multiple Sclerosis
Keywords
Immunomodulating treatment
Cohort study
Dimethyl fumarate
Fingolimod
Interferon-beta
Natalizumab
Rituximab
Glatiramer acetate
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Yes
Target Follow-Up Duration
3 Years
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
Retention
Enrollment
3,526Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rituximab
Drug
Comparisons of efficacy and safety between rituximab and all other frequently used immunomodulating drugs against multiple sclerosis
Natalizumab
Fingolimod
Alemtuzumab
Interferon-beta
Glatiramer acetate
Dimethyl Fumarate
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
Proportion of patients with baseline EDSS <2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up.
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
3 years
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
- Proportion of patients with baseline EDSS ≥2.5 experiencing 12 months confirmed EDSS increase of 1 point among those over 3 years of follow up
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
3 years
Disease-related Impact on Daily Life, Physical
- Change in the MSIS-29 physical subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) physical subscale measures patient-reported physical impact of multiple sclerosis.
Disease-related Impact on Daily Life, Psychological
- Change in the MSIS-29 psychological subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) psychological subscale measures patient-reported psychological impact of multiple sclerosis.
- Comparison of mean number of relapses per year between the different treatments
3 years
Remaining on Drug
- Proportion remaining on the index DMT after 3 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA:
The study population consists of all patients with Clinically Isolated Syndrome (CIS) or RRMS who;
Initiate a first MS DMT (treatment naïve), or Initiate a second ever DMT, of a different drug class than the first, regardless of time between drugs or reason for discontinuation("switchers") from 1st Jan 2011 to 30st June 2018, and
Are followed at any of the University clinics of Sweden, and
Consent to participation in COMBAT-MS core, and
Are expected to be capable to follow study assessments.
EXCLUSION CRITERIA:
- Patients with progressive forms of MS at start of therapy are not eligible
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
All patients initiated at their first or second disease-modifying drug between January 1 2011 and June 30 2018 will be included in the trial. Up to present date, study-related data will be retrospectively controlled via individual study of patient records. Patients will be identified through the Swedish MS registry. Inclusion into the COMBAT-MS core study will be subject to written informed consent. Given the non-intervention design of the study and very limited study-specific procedures outside of clinical practise, we expect participation rates to be very high. Based on preliminary calculations from the MS registry the projected number of participants will be 3700 patients, out of which at least 1000 are treated with rituximab first or second-line.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Fredrik Piehl, MD, PhD
Karolinska Institutet
Principal Investigator
Anders Svenningsson, MD, PhD
Karolinska Institutet
Principal Investigator
Anna Fogdell-Hahn, PhD
Karolinska Institutet
Principal Investigator
Ingrid Kockum, PhD
Karolinska Institutet
Principal Investigator
Thomas Frisell, PhD
Karolinska Institutet
Principal Investigator
Annette Langer-Gould, MD, PhD
Kaiser Permanent Southern California, Los Angeles, USA
Englund S, Frisell T, Qu Y, Gandhi K, Hulten A, Kierkegaard M, Piehl F, Longinetti E. Trajectories of self-reported fatigue following initiation of multiple sclerosis disease-modifying therapy. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1012-1020. doi: 10.1136/jnnp-2024-333595.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Note that unique patients could contribute to more than one treatment group, both with their first line and second line DMT, or exclusively in the first line or second line DMT group, as based on baseline characteristics. The 'total' automatically summed across groups should be interpreted as the total number of participants in first line DMT and second line DMT, respectively.
Type of Units Analyzed
Treatment Episodes
Arm/Group Information
ID
Title
Description
FG000
RTX (First Line)
Rituximab (First line)
FG001
IFN (First Line)
Interferons, first line DMT
FG002
GA (First Line)
Glatiramer acetate, first line DMT
FG003
DMF (First Line)
Dimethyl fumarate, first line DMT
FG004
NTZ (First Line)
Natalizumab, first line DMT
FG005
RTX (Second Line)
Rituximab, as first second line DMT
FG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
FG007
NTZ (Second Line)
Natalizumab, as first second line DMT
FG008
FGL (Second Line)
Fingolimod, as first second line DMT
FG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Periods
Title
Milestones
Reasons Not Completed
First Line
Type
Comment
Milestone Data
STARTED
FG000591 subjects591 units
FG001992 subjects992 units
FG002116 subjects116 units
FG003416 subjects416 units
FG004334 subjects334 units
FG0050 subjects0 units
FG0060 subjects0 units
FG0070 subjects0 units
FG0080 subjects0 units
FG0090 subjects0 units
COMPLETED
FG000591 subjects591 units
FG001992 subjects992 units
FG002116 subjects116 units
FG003416 subjects
NOT COMPLETED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG0030 subjects0 units
Second Line
Type
Comment
Milestone Data
STARTED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Unique patients could conribute to more than one treatment group, both with their first line and second line DMT
Type of Units Analyzed
Treatment Episodes
Arm/Group Information
ID
Title
Description
BG000
RTX (First Line)
Rituximab (First line)
BG001
IFN (First Line)
Interferons, first line DMT
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
First line and Second line reported in separate rows
Outcome Measures Module
Outcome Measures
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
Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
Proportion of patients with baseline EDSS <2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up.
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Adverse Events Module
Frequency Threshold
0
Time Frame
4 years and 9 months, during prospective data collection between 2017 and 2022
Description
Per regulatory approval by the Swedish Medical Products Agency (MPA), the prospective data collection only included Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including All-Cause Mortality. Other adverse events were not collected (i.e., "0" Total Number of participants at risk). Events were collected from annual safety reports to the MPA, which did not include information on line of therapy. Thus, no stratification on therapy line was done.
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
RTX (First or Second Line)
Rituximab, as first line or second line DMT
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
COMBAT was an observational real-world study assessing the outcomes of different DMTs as used according to clinical practice. The assignment of treatments was not under investigator control, there was no randomization and no blinding of treatments. Although differences in patient characteristics at treatment start was accounted for by statistical modelling, the risk of residual confounding should be kept in mind.
Serum samples will be taken yearly for analysis of anti-drug antibodies. These samples will be saved in biobank.
Additional blood samples will be taken for analyses of SARS-CoV-2 serologic response.
3 years
Increase in EDSS
- Comparison of yearly increase in mean EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
3 years
Proportion of Patients With at Least 1 Step Increase in EDSS
- Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
3 years
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
- Comparison of yearly proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments.
Comparison of health-related quality of life measured by the European Quality of Life Five Dimensions (EQ-5D). Higher values indicate better health, and lower values indicate poorer health. The maximum theoretical value is 1. While there is no fixed minimum, scores can fall below 0, indicating health states worse than death. In this study, scores ranged from -0.59 to 1, which represent clinically relevant ranges of values.
3 years
Fatigue
Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC).
The fatigue scale for motor and cognitive functions (FSMC) scale range: Minimum score: 20. Maximum score: 100. Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
3 years
Treatment Satisfaction
Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ), items 1-9, restricted to patients remaining on index DMT at 3 years.
- Rate of serious infections, defined as hospitalizations where the main diagnosis included an ICD-10 diagnosis code in the national patient register in the 3 years after initiating index DMT
3 years
Rate of Major Adverse Cardiovascular Events (MACE)
- Rate of MACE, defined as acute coronary syndrome, stroke or death from any cardiovascular cause based on corresponding ICD-codes in the national patient and cause of death registries in the 3 years after initiating index DMT
3 years
Rate of Invasive Cancer
- Rate of incident invasive cancer, defined as invasive cancers based on corresponding ICD-codes in the national cancer registry in the 3 years after initiating index DMT.
3 years
416 units
FG004334 subjects334 units
FG0050 subjects0 units
FG0060 subjects0 units
FG0070 subjects0 units
FG0080 subjects0 units
FG0090 subjects0 units
FG0040 subjects0 units
FG0050 subjects0 units
FG0060 subjects0 units
FG0070 subjects0 units
FG0080 subjects0 units
FG0090 subjects0 units
0 subjects
0 units
FG0040 subjects0 units
FG005748 subjects748 units
FG006570 subjects570 units
FG007541 subjects541 units
FG008443 subjects443 units
FG009161 subjects161 units
COMPLETED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG0030 subjects0 units
FG0040 subjects0 units
FG005748 subjects748 units
FG006570 subjects570 units
FG007541 subjects541 units
FG008443 subjects443 units
FG009161 subjects161 units
NOT COMPLETED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG0030 subjects0 units
FG0040 subjects0 units
FG0050 subjects0 units
FG0060 subjects0 units
FG0070 subjects0 units
FG0080 subjects0 units
FG0090 subjects0 units
BG002
GA (First Line)
Glatiramer acetate, first line DMT
BG003
DMF (First Line)
Dimethyl fumarate, first line DMT
BG004
NTZ (First Line)
Natalizumab, first line DMT
BG005
RTX (Second Line)
Rituximab, as first second line DMT
BG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
BG007
NTZ (Second Line)
Natalizumab, as first second line DMT
BG008
FGL (Second Line)
Fingolimod, as first second line DMT
BG009
TFL (Second Line)
Teriflunomide, as first second line DMT
BG010
Total
Total of all reporting groups
591
BG001992
BG002116
BG003416
BG004334
BG005748
BG006570
BG007541
BG008443
BG009161
BG0103764
Treatment Episodes
BG000591
BG001992
BG002116
BG003416
BG004334
BG005748
BG006570
BG007541
BG008443
BG009161
BG0104912
Mean
Standard Deviation
years
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG00036.9± 11.3
BG00135.8± 10.5
BG00236.9± 11.7
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Sex: Female, Male
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
Female
BG000399
BG001705
BG00290
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Participants
Units
Counts
Participants
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Treatment Episodes
BG000591
BG001992
BG002116
BG003416
BG004
Title
Denominators
Categories
Title
Measurements
BG0100
Region of Enrollment
First line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
Number
participants
Participants
Units
Counts
Participants
BG000591
BG001992
BG002116
BG003416
BG004334
BG0050
BG0060
BG0070
BG0080
BG0090
BG0102449
Treatment Episodes
BG000591
BG001992
BG002116
BG003416
BG004
Title
Denominators
Categories
Sweden
Title
Measurements
BG000591
BG001992
BG002116
BG003
Region of Enrollment
Second line reported separately as unique patients could contribute to more than one treatment groups, both with their first line and secoond line DMT
Number
participants
Participants
Units
Counts
Participants
BG0000
BG0010
BG0020
BG0030
BG0040
BG005748
BG006570
BG007541
BG008443
BG009161
BG0102463
Treatment Episodes
BG000591
BG001992
BG002116
BG003416
BG004
Title
Denominators
Categories
Sweden
Title
Measurements
BG005748
BG006570
BG007541
BG008
Year of DMT start
First line and Second line reported in separate rows
Median
Inter-Quartile Range
year
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG0002016(2015 to 2017)
BG0012013(2012 to 2014)
BG0022013(2012 to 2014)
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Born in Sweden
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG000494
BG001782
BG00298
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Education, 12+ years
n (%) with at least 12 years of education
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG000310
BG001545
BG00261
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Years since MS diagnosis
First line and Second line reported in separate rows
Mean
Standard Deviation
years
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG0001.3± 4.0
BG0010.9± 3.1
BG0021.7± 4.5
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Any relapse last year
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG000367
BG001648
BG00262
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
EDSS
Mean (Standard Deviation) Expanded Disability Status Scale (EDSS)
Scale range:
Minimum score: 0 (normal neurological examination) Maximum score: 10 (death due to multiple sclerosis)
First line and Second line reported in separate rows
Mean
Standard Deviation
units on a scale
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG0002.4± 1.0
BG0012.2± 0.9
BG0022.6± 0.9
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Serious infection
n (%) with hospitalization due to infection in the last five years
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG00015
BG00121
BG0021
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Cancer
n (%) with any diagnosis of invasive cancer in the last five years
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG0004
BG00110
BG0023
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Antidepressant use
n (%) with any filled prescription of antidepressant last year.
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG00088
BG00198
BG00225
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
MACE
n (%) with any diagnosis major adverse cardiovascular event (MACE) in the last five years
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG0009
BG00110
BG0024
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Arrhythmia
n (%) with any diagnosis of arrythmia in the last five years
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG00010
BG0017
BG0020
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Diabetes
n (%) with any diagnosis of diabetes in the last five years
First line and Second line reported in separate rows
Count of Participants
Participants
Participants
Title
Denominators
Categories
First line
ParticipantsBG000591
ParticipantsBG001992
ParticipantsBG002116
ParticipantsBG003416
ParticipantsBG004334
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG0102449
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004
Title
Measurements
BG00013
BG00117
BG0022
BG003
Second line
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00020
OG00150
OG0025
OG003
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.5
2-Sided
95
-1.8
4.9
Superiority
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-0.2
2-Sided
95
-6.8
6.5
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.3
2-Sided
95
-1.7
4.3
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-0.9
2-Sided
95
-4.3
2.4
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.7
2-Sided
95
-1.3
4.6
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.3
2-Sided
95
-2.7
3.3
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.2
2-Sided
95
-2.0
4.4
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
2.0
2-Sided
95
-3.2
7.1
Superiority
Primary
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
- Proportion of patients with baseline EDSS ≥2.5 experiencing 12 months confirmed EDSS increase of 1 point among those over 3 years of follow up
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.7
2-Sided
95
-7.5
8.8
Superiority
Primary
Disease-related Impact on Daily Life, Physical
- Change in the MSIS-29 physical subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) physical subscale measures patient-reported physical impact of multiple sclerosis.
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.4
2-Sided
95
-2.5
3.3
Superiority
Primary
Disease-related Impact on Daily Life, Psychological
- Change in the MSIS-29 psychological subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) psychological subscale measures patient-reported psychological impact of multiple sclerosis.
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
2.3
2-Sided
95
-2.2
6.8
Superiority
Secondary
Annualized Relapse Rate
- Comparison of mean number of relapses per year between the different treatments
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
percentage of relapses
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.39
2-Sided
95
0.30
0.48
Superiority
Secondary
Remaining on Drug
- Proportion remaining on the index DMT after 3 years
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-71.6
2-Sided
95
-76.6
-66.6
Superiority
Secondary
Increase in EDSS
- Comparison of yearly increase in mean EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.1
2-Sided
95
-0.1
0.3
Superiority
Secondary
Proportion of Patients With at Least 1 Step Increase in EDSS
- Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
4.8
2-Sided
95
-2.2
11.9
Superiority
Secondary
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
- Comparison of yearly proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments.
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-34.1
2-Sided
95
-40.3
-27.9
Superiority
Secondary
Proportion of Patients With NEDA-3
- Comparison of yearly proportion of patients with NEDA-3 (NEDA-2 plus no confirmed worsening of EDSS from baseline).
First line and Second line reported in separate rows
Posted
Count of Participants
Participants
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-33.2
2-Sided
95
-39.4
-27.0
Superiority
Secondary
Quality of Life Assessments
Comparison of health-related quality of life measured by the European Quality of Life Five Dimensions (EQ-5D). Higher values indicate better health, and lower values indicate poorer health. The maximum theoretical value is 1. While there is no fixed minimum, scores can fall below 0, indicating health states worse than death. In this study, scores ranged from -0.59 to 1, which represent clinically relevant ranges of values.
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.03
2-Sided
95
-0.07
0.00
Superiority
Secondary
Fatigue
Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC).
The fatigue scale for motor and cognitive functions (FSMC) scale range: Minimum score: 20. Maximum score: 100. Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
0.9
2-Sided
95
-3.3
5.2
Superiority
Secondary
Treatment Satisfaction
Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ), items 1-9, restricted to patients remaining on index DMT at 3 years.
First line and Second line reported in separate rows
Posted
Mean
Standard Deviation
units on a scale
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000544
OG001282
OG00236
OG003
Title
Denominators
Categories
First line
ParticipantsOG000544
ParticipantsOG001282
ParticipantsOG00236
ParticipantsOG003
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
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-5.5
2-Sided
95
-8.1
-2.9
Superiority
Secondary
Rate of Serious Infections
- Rate of serious infections, defined as hospitalizations where the main diagnosis included an ICD-10 diagnosis code in the national patient register in the 3 years after initiating index DMT
First line and Second line reported in separate rows
Posted
Number
95% Confidence Interval
infections per 1000 person-years
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
Secondary
Rate of Major Adverse Cardiovascular Events (MACE)
- Rate of MACE, defined as acute coronary syndrome, stroke or death from any cardiovascular cause based on corresponding ICD-codes in the national patient and cause of death registries in the 3 years after initiating index DMT
First line and Second line reported in separate rows
Posted
Number
95% Confidence Interval
MACE per 1000 person-years
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
Secondary
Rate of Invasive Cancer
- Rate of incident invasive cancer, defined as invasive cancers based on corresponding ICD-codes in the national cancer registry in the 3 years after initiating index DMT.
First line and Second line reported in separate rows
Posted
Number
95% Confidence Interval
invasive cancer per 1000 person-years
3 years
ID
Title
Description
OG000
RTX (First Line)
Rituximab (First line)
OG001
IFN (First Line)
Interferons, first line DMT
OG002
GA (First Line)
Glatiramer acetate, first line DMT
OG003
DMF (First Line)
Dimethyl fumarate, first line DMT
OG004
NTZ (First Line)
Natalizumab, first line DMT
OG005
RTX (Second Line)
Rituximab, as first second line DMT
OG006
DMF (Second Line)
Dimethyl fumarate, as first second line DMT
OG007
NTZ (Second Line)
Natalizumab, as first second line DMT
OG008
FGL (Second Line)
Fingolimod, as first second line DMT
OG009
TFL (Second Line)
Teriflunomide, as first second line DMT
Units
Counts
Participants
OG000591
OG001992
OG002116
OG003
Title
Denominators
Categories
First line
ParticipantsOG000591
ParticipantsOG001992
ParticipantsOG002116
ParticipantsOG003
1,184
43
1,184
0
0
EG001
IFN (First Line)
Interferons, first line DMT
0
884
1
884
0
0
EG002
GA (First Line)
Glatiramer acetate, first line DMT
0
97
0
97
0
0
EG003
DMF (First or Second Line)
Dimethyl fumarate, as first line or second line DMT
0
870
1
870
0
0
EG004
NTZ (First or Second Line)
Natalizumab, as first line or second line DMT
0
767
3
767
0
0
EG005
FGL (First Line)
Fingolimod, first line DMT
0
384
3
384
0
0
EG006
TFL (First Line)
Teriflunomide, first line DMT
1
138
3
138
0
0
EG0006 events6 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0051 events1 affected384 at risk
EG0060 events0 affected138 at risk
Serum sickness
Immune system disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 events2 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Hepatitis viral
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Pyrexia
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Appendicitis
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 events2 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Cardiac failure
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0002 events2 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Lung neoplasma malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0051 events1 affected384 at risk
EG0060 events0 affected138 at risk
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0011 events1 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0061 events1 affected138 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Sepsis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Hypogammaglobulinaemia
Immune system disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Haemophilus sepsis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Encephalitis viral
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Cervix carcinoma stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Completed suicide
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Abort spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0041 events1 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Colitis
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Abdominal abscess
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Myocarditis
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Corona virus infections
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0006 events6 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Staphylococcal infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0062 events2 affected138 at risk
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Crohn's disease
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0041 events1 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Lyme disease
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Large granular lymphocytosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Neuroborreliosis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0051 events1 affected384 at risk
EG0060 events0 affected138 at risk
Pulmonary embolism
Vascular disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0041 events1 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Follicle centre lymphoma, follicular grade I, II, III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0031 events1 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Inflammatory bowel disease
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected1,184 at risk
EG0010 events0 affected884 at risk
EG0020 events0 affected97 at risk
EG0030 events0 affected870 at risk
EG0040 events0 affected767 at risk
EG0050 events0 affected384 at risk
EG0060 events0 affected138 at risk
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D061067
Antibodies, Monoclonal, Humanized
D013110
Sphingosine
D000605
Amino Alcohols
D000438
Alcohols
D009930
Organic Chemicals
D011409
Propylene Glycols
D006018
Glycols
D000588
Amines
D007370
Interferon Type I
D007372
Interferons
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
D010455
Peptides
D001685
Biological Factors
D005650
Fumarates
D003998
Dicarboxylic Acids
D000144
Acids, Acyclic
D002264
Carboxylic Acids
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
34.4
± 9.7
BG00431.6± 9.2
BG01035.3± 10.6
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG00539.0± 10.5
BG00640.6± 10.6
BG00735.1± 9.6
BG00837.3± 9.4
BG00946.3± 9.8
BG01038.7± 10.5
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
283
BG004242
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101719
Male
BG000192
BG001287
BG00226
BG003133
BG00492
BG0050
BG0060
BG0070
BG0080
BG0090
BG010730
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
Female
BG005560
BG006418
BG007406
BG008292
BG009116
BG0101792
Male
BG005188
BG006152
BG007135
BG008151
BG009
334
BG005748
BG006570
BG007541
BG008443
BG009161
BG0104912
334
BG005748
BG006570
BG007541
BG008443
BG009161
BG0104912
416
BG004334
BG0102449
334
BG005748
BG006570
BG007541
BG008443
BG009161
BG0104912
443
BG009161
BG0102463
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
2015
(2014 to 2017)
BG0042014(2013 to 2016)
BG0102014(2012 to 2016)
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0052016(2014 to 2017)
BG0062015(2014 to 2016)
BG0072013(2012 to 2014)
BG0082013(2012 to 2014)
BG0092015(2015 to 2017)
BG0102014(2013 to 2016)
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
337
BG004278
BG0101989
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG005605
BG006466
BG007460
BG008361
BG009139
BG0102031
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
226
BG004161
BG0101303
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG005403
BG006309
BG007272
BG008234
BG00989
BG0101307
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
0.6
± 2.3
BG0040.5± 1.9
BG0100.9± 3.2
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0055.6± 5.5
BG0067.1± 5.9
BG0074.7± 4.8
BG0085.6± 4.8
BG0099.3± 6.9
BG0106.0± 5.6
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
265
BG004252
BG0101594
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG005254
BG006120
BG007288
BG008172
BG00930
BG010864
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
1.5
± 1.1
BG0042.1± 1.3
BG0101.7± 1.2
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0052.0± 1.3
BG0061.6± 1.3
BG0072.2± 1.4
BG0081.8± 1.3
BG0091.8± 1.6
BG0101.9± 1.4
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
1.7
± 0.8
BG0042.0± 0.9
BG0101.8± 0.8
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0051.7± 0.8
BG0061.6± 0.7
BG0071.9± 0.9
BG0081.7± 0.8
BG0091.7± 0.7
BG0101.8± 0.8
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
2.3
± 1.0
BG0042.6± 1.0
BG0102.4± 1.0
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0052.2± 1.0
BG0062.0± 0.9
BG0072.4± 1.0
BG0082.2± 0.9
BG0092.1± 1.0
BG0102.2± 1.0
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
7
BG00416
BG01060
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG00521
BG00617
BG00721
BG00812
BG0096
BG01077
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
4
BG0043
BG01024
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG00510
BG00610
BG0072
BG0086
BG0097
BG01035
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
64
BG00435
BG010310
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG005124
BG00692
BG007108
BG00881
BG00942
BG010447
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
2
BG0043
BG01028
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG0056
BG0066
BG0075
BG0081
BG0094
BG01022
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
2
BG0042
BG01021
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG00511
BG0065
BG0078
BG0086
BG0091
BG01031
334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
4
BG0047
BG01043
Participants
BG004
0
ParticipantsBG005748
ParticipantsBG006570
ParticipantsBG007541
ParticipantsBG008443
ParticipantsBG009161
ParticipantsBG0102463
Treatment EpisodesBG000591
Treatment EpisodesBG001992
Treatment EpisodesBG002116
Treatment EpisodesBG003416
Treatment EpisodesBG004334
Treatment EpisodesBG005748
Treatment EpisodesBG006570
Treatment EpisodesBG007541
Treatment EpisodesBG008443
Treatment EpisodesBG009161
Treatment EpisodesBG0104912
Title
Measurements
BG00517
BG00612
BG0076
BG0085
BG0092
BG01042
14
OG0047
OG0050
OG0060
OG0070
OG0080
OG0090
Participants
OG004
0
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG00518
OG00625
OG00719
OG00819
OG0098
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00050
OG001111
OG0029
OG00330
OG00432
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG00550
OG00657
OG00747
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-2.9
2-Sided
95
-18.5
12.8
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-0.1
2-Sided
95
-8.8
8.6
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-0.5
2-Sided
95
-8.1
7.2
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.6
2-Sided
95
-5.7
8.9
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
1.6
2-Sided
95
-4.7
8.0
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.9
2-Sided
95
-6.2
7.9
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-1.6
2-Sided
95
-10.8
7.5
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000-1.4± 16.6
OG0011.1± 16.2
OG002-4.8± 17.7
OG003-1.2± 16.1
OG004-6.3± 18.0
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005-0.3± 14.5
OG006-0.5± 13.3
OG007-2.1± 16.4
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-4.5
2-Sided
95
-12.5
3.4
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.3
2-Sided
95
-2.5
1.8
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-2.5
2-Sided
95
-4.9
-0.1
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.7
2-Sided
95
-2.6
1.1
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-1.9
2-Sided
95
-4.2
0.3
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-1.8
2-Sided
95
-4.0
0.3
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
2.6
2-Sided
95
-0.6
5.8
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000-8.5± 21.3
OG001-5.1± 20.7
OG002-23.1± 23.8
OG003-6.8± 20.7
OG004-12.2± 22.3
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005-3.7± 19.5
OG006-1.7± 19.3
OG007-6.1± 20.5
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-8.3
2-Sided
95
-20.3
3.7
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.4
2-Sided
95
-2.6
3.5
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-2.4
2-Sided
95
-5.8
0.9
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.1
2-Sided
95
-2.9
2.7
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-1.5
2-Sided
95
-4.5
1.6
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-1.6
2-Sided
95
-4.7
1.5
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
2.3
2-Sided
95
-1.7
6.4
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0000.08± 0.31
OG0010.59± 0.94
OG0020.47± 0.73
OG0030.26± 0.53
OG0040.26± 0.63
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG0050.09± 0.34
OG0060.22± 0.54
OG0070.30± 0.67
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.27
2-Sided
95
0.11
0.42
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.17
2-Sided
95
0.10
0.23
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.05
2-Sided
95
-0.03
0.13
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.14
2-Sided
95
0.08
0.19
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.09
2-Sided
95
0.01
0.16
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.14
2-Sided
95
0.06
0.21
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.23
2-Sided
95
0.13
0.33
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000527
OG001300
OG00240
OG003191
OG004167
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005662
OG006307
OG007299
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-66.3
2-Sided
95
-76.3
-56.4
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-47.3
2-Sided
95
-53.0
-41.7
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-43.1
2-Sided
95
-49.6
-36.6
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-41.3
2-Sided
95
-46.4
-36.2
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-33.9
2-Sided
95
-39.8
-28.0
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-33.9
2-Sided
95
-39.7
-28.0
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-49.8
2-Sided
95
-58.0
-41.6
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000-0.2± 1.2
OG0010.1± 1.2
OG0020.2± 1.2
OG003-0.2± 1.1
OG004-0.4± 1.2
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005-0.0± 0.9
OG0060.1± 0.9
OG007-0.1± 1.1
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.1
2-Sided
95
-0.3
0.4
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.1
2-Sided
95
-0.2
0.1
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.1
2-Sided
95
-0.3
0.1
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.0
2-Sided
95
-0.1
0.1
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
-0.1
2-Sided
95
-0.2
0.1
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.0
2-Sided
95
-0.1
0.2
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Net)
0.1
2-Sided
95
-0.1
0.3
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000108
OG001272
OG00243
OG00383
OG00444
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005135
OG006114
OG007117
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
9.0
2-Sided
95
-2.6
20.6
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-0.7
2-Sided
95
-7.6
6.2
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-2.6
2-Sided
95
-9.4
4.1
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-2.6
2-Sided
95
-8.6
3.4
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
3.8
2-Sided
95
-4.7
12.2
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
0.6
2-Sided
95
-6.9
8.1
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
3.9
2-Sided
95
-6.3
14.1
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000483
OG001348
OG00244
OG003235
OG004208
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005638
OG006356
OG007326
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-32.2
2-Sided
95
-43.0
-21.5
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-21.8
2-Sided
95
-27.9
-15.7
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-7.8
2-Sided
95
-14.5
-1.2
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-23.6
2-Sided
95
-28.9
-18.3
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-12.7
2-Sided
95
-18.9
-6.5
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-26.5
2-Sided
95
-32.8
-20.2
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-31.7
2-Sided
95
-40.1
-23.2
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG000467
OG001340
OG00243
OG003232
OG004204
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG005619
OG006339
OG007314
OG008
OG000
OG002
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-30.6
2-Sided
95
-41.4
-19.8
Superiority
OG000
OG003
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-20.8
2-Sided
95
-27.0
-14.7
Superiority
OG000
OG004
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-7.0
2-Sided
95
-13.6
-0.3
Superiority
OG005
OG006
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-23.7
2-Sided
95
-29.2
-18.3
Superiority
OG005
OG007
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-12.3
2-Sided
95
-18.6
-6.1
Superiority
OG005
OG008
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-25.3
2-Sided
95
-31.7
-19.0
Superiority
OG005
OG009
Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Difference in proportion
-29.5
2-Sided
95
-38.2
-20.8
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0000.77± 0.24
OG0010.77± 0.24
OG0020.74± 0.26
OG0030.81± 0.22
OG0040.76± 0.26
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG0050.76± 0.24
OG0060.81± 0.22
OG0070.74± 0.27
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.02
2-Sided
95
-0.09
0.06
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.00
2-Sided
95
-0.03
0.03
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
0.01
2-Sided
95
-0.03
0.05
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
0.01
2-Sided
95
-0.02
0.04
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
0.03
2-Sided
95
-0.01
0.06
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
0.03
2-Sided
95
0.00
0.06
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.02
2-Sided
95
-0.06
0.03
Superiority
416
OG004334
OG005748
OG006570
OG007541
OG008443
OG009161
416
ParticipantsOG004334
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00055.1± 22.9
OG00152.1± 23.0
OG00255.7± 22.2
OG00348.3± 23.0
OG00453.2± 23.2
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005748
ParticipantsOG006570
ParticipantsOG007541
ParticipantsOG008443
ParticipantsOG009161
Title
Measurements
OG00553.5± 23.0
OG00649.7± 21.6
OG00755.9± 23.0
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-1.5
2-Sided
95
-9.4
6.4
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-1.4
2-Sided
95
-4.2
1.4
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-2.6
2-Sided
95
-5.9
0.8
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.2
2-Sided
95
-2.9
2.5
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-1.1
2-Sided
95
-4.0
1.8
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-3.1
2-Sided
95
-7.0
0.9
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
1.3
2-Sided
95
-2.9
5.4
Superiority
191
OG004168
OG005692
OG006309
OG007303
OG008263
OG00977
191
ParticipantsOG004168
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG00050.1± 6.8
OG00144.3± 7.7
OG00242.8± 8.3
OG00348.3± 7.1
OG00449.5± 6.7
Second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG005692
ParticipantsOG006309
ParticipantsOG007303
ParticipantsOG008263
ParticipantsOG00977
Title
Measurements
OG00549.5± 7.2
OG00649.0± 6.7
OG00749.5± 6.7
OG008
OG000
OG002
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-5.9
2-Sided
95
-10.9
-1.0
Superiority
OG000
OG003
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-2.4
2-Sided
95
-4.0
-0.8
Superiority
OG000
OG004
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.3
2-Sided
95
-2.1
1.5
Superiority
OG005
OG006
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
-0.8
2-Sided
95
-2.2
0.6
Superiority
OG005
OG007
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
1.3
2-Sided
95
-0.3
2.8
Superiority
OG005
OG008
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.
Mean Difference (Final Values)
2.7
2-Sided
95
0.9
4.6
Superiority
OG005
OG009
Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.