A Multi-Site, Open-Label Extension Trial of Oral RPC1063... | NCT02576717 | Trialant
NCT02576717
Sponsor
Celgene
Status
Completed
Last Update Posted
Jan 30, 2024Actual
Enrollment
2,494Actual
Phase
Phase 3
Conditions
Multiple Sclerosis
Interventions
RPC1063
Countries
United States
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Estonia
Georgia
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Moldova
New Zealand
Poland
Portugal
Romania
Serbia
Slovakia
South Africa
Spain
Sweden
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02576717
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RPC01-3001
Secondary IDs
Not provided
Brief Title
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 16, 2015Actual
Primary Completion Date
Jan 5, 2023Actual
Completion Date
Jan 5, 2023Actual
First Submitted Date
Sep 28, 2015
First Submission Date that Met QC Criteria
Oct 13, 2015
First Posted Date
Oct 15, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 12, 2023
Results First Submitted that Met QC Criteria
Jan 3, 2024
Results First Posted Date
Jan 30, 2024Actual
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
Jan 3, 2024
Last Update Posted Date
Jan 30, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Detailed Description
The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.
Conditions Module
Conditions
Multiple Sclerosis
Keywords
MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,494Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1 mg RPC1063 (Ozanimod) oral capsule
Experimental
1 mg RPC1063 (Ozanimod) oral capsule daily
Drug: RPC1063
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RPC1063
Drug
1 mg RPC1063 (Ozanimod) oral capsule
Ozanimod
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
Secondary Outcomes
Measure
Description
Time Frame
Annualized Relapse Rate (ARR)
The Annualized Relapse Rate (ARR) is the average number of relapses per study arm in one year. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days. The adjusted ARR was based on the negative binomial regression model with parent treatment group, adjusted for region (Eastern Europe vs Rest of World), age at parent baseline, and the parent baseline number of gadolinium-enhanced (GdE) lesions. The natural log transformation of time on treatment was used as an offset term to adjust for participants having different exposure times.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Eligibility Criteria:
To be eligible to participate in this trial, patients must meet all of the following criteria:
Completed one of the parent trials
Does not have a condition that would require withdrawal from one of the parent trials
Has no conditions requiring treatment with a prohibited concomitant medication
Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
At Baseline (Day 1)
CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
Acceptable methods of birth control in this study are the following:
Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
Placement of an intrauterine device (IUD)
Placement of an intrauterine hormone-releasing system (IUS)
Rubin DT, Danese S, Nakase H, Ungaro RC, Wolf DC, Alekseeva O, Petersen A, Liu Z, Mehra D, Jain A, Osterman MT, Krakovich A, Riolo JV, DeBoer E, Appio J, Sinh P, Cree BAC, Cohen JA, Irving P. Integrated long-term safety of 10-year ozanimod treatment: results from clinical trials in patients with moderate-to-severe ulcerative colitis or relapsing multiple sclerosis. Inflamm Bowel Dis. 2026 May 1;32(5):954-962. doi: 10.1093/ibd/izaf319.
Participants were Pooled According to Treatment Assignment in Parent Trial. A total of 2494 participants were treated, however, in the parent treatment groups 3 participants planned for IFN β-1a received RPC1063 0.5 mg, 1 participant planned for IFN β 1a received RPC1063 1 mg, and 1 participant planned for ozanimod 0.5 mg received RPC1063 1 mg. The parent placebo 0.5 mg and 1 mg study groups were consolidated into the 0.5 mg and 1 mg RPC1063 groups.
Recruitment Details
Participants must have participated in Trial RPC01-201, Trial RPC01-301, and/or Trial RPC01-1001 prior to joining RPC01-3001.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Started = ITT Participants were included in the treatment group based on the planned treatment (received at randomization) in the parent study.
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 8, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Russia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants Experiencing Adverse Events (AEs) of Special Interest
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
An absolute lymphocyte count (ALC) is a part of a blood test that measures the number of lymphocytes, a type of white blood cell, in the blood. Lymphocytes help fight infections and diseases. Reductions in ALC levels for participants in this study is expected and is a primary pharmacodynamic effect of RPC1063.
LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in White Blood Cell Count (WBC)
A white blood cell count is a part of a blood test that measures the number of white blood cells in the blood. White blood cells help fight infections and diseases.
LLN = Lower limit of normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
An absolute neutrophil count is a part of a blood test that measures the number of neutrophils, a type of white blood cell, in the blood. Neutrophils help fight infections and diseases.
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Abnormalities in Specific Liver Function Tests
The number of participants with laboratory abnormalities in specific liver tests above ULN by category. ULN = Upper Limit of Normal
From first dose up until last dose of study treatment (up to approximately 82 months)
Number of Participants With Electrocardiogram (ECG) Result Abnormalities
An electrocardiogram (ECG) measures electrical activity of the heart to detect cardiac problems.
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
Vital signs included body temperature, sitting heart rate/pulse (HR), sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP).
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and 60 months after first dose of study therapy
Number of Participants With Physical Examination Abnormalities
The number of participants with abnormal physical examination results. The assessments included abdominal, extremity, head, heart, lungs, neck, neurological non-MS, other and skin assessments.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 84 months post first dose.
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide). Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 3 months thereafter up until 78 months post first dose.
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide).
1, 4, 7, 14, 21, 28, and 90 days post last dose.
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
The PWC-20 is a rater-administered 20-item scale to assess signs and symptoms of withdrawal. Twenty items are rated on a 4-point scale as not present (0 points), mild (1 point), moderate (2 points), or severe (3 points). The points from all items are calculated as a total score. Higher scores indicate more severe withdrawal symptoms.
1, 4, 7, 14, 21, and 90 days post last dose.
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
The HADS is a validated patient reported outcome for assessing anxiety and depression. It consists of 14 items in total, 7 items related to anxiety and 7 items related to depression. For each item patients select a statement (valued at 0 to 3 points) that closest matches their own feeling over the past week. Separate total scores for anxiety and depression are derived by adding up points. Total scores can range from 0 to 21 points. Higher scores indicate more severe anxiety and depression and scores of 8 to 10 are generally considered indicative of borderline anxiety/depression disorders and scores of 11 and higher are generally considered indicative of anxiety/depression disorders.
1, 4, 7, 14, 21, and 90 days post last dose.
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
The ESS is a validated self administered questionnaire with 8 questions. Respondents rate on a 4-point scale (0 to 3) their chances of dozing off or falling asleep while engaged in 8 different activities. The ESS score is the sum of 8 item scores and can range from 0 to 24 points. Higher scores indicate more daytime sleepiness.
1, 4, 7, 14, 21, and 90 days post last dose.
Changes in Vital Sign Values From Last Day on Treatment
From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Time to First Relapse (TFR)
The time between first dose of study treatment and first relapse if experienced by a participant. A participant was censored if follow-up ended before a relapse occurred, whether due to the participant completing study, withdrawing from the study, or due to the cutoff of data collection for the analysis. The censor date was the date of the end of study or the date of the data cutoff for participant who were ongoing. Participants who withdrew from the study after the baseline visit were censored at the last known date while on study. Based on Kaplan-Meier product limit estimates.
Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
Number of Participants Who Were Relapse Free
The number of participants who did not experience relapse. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
Adjusted Mean of new enlarging T2 lesions per scan at each visit. Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and baseline number of GdE lesions.
T2 Magnetic Resonance Imaging (MRI) sequences are used to highlight areas of demyelination in brain neurons, which happens when the outer layer of the neurons is damaged due to multiple sclerosis (MS) activity. T2 sequences can be used to count the total number of MS lesions, which look like bright white spots on T2 sequences, and can be called "hyperintense".
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
Number of gadolinium-enhanced (GdE) (also called GdE enhanced T1) brain MRI lesions per scan at each visit.
Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Time to Onset of Disability Progression as Defined by a Sustained Worsening in Expanded Disability Status Scale (EDSS)
Multiple sclerosis (MS) disability progression is defined as a sustained worsening in EDSS of 1.0 points or more from baseline, confirmed after a 3-month and 6-month period. The EDSS is a standardized method, widely accepted, numerical scale used to evaluate disability in people with multiple sclerosis (MS). The EDSS is evaluated according to signs and symptoms observed during a standard neurological examination. These clinical observations are classified in 7 FS scales, each of them grading signs and symptoms for different neurological functions: pyramidal, cerebellar, brainstem, sensory, bowel or bladder, visual, and cerebral.
Derived using Kaplan-Meier estimates.
At 3 and 6 months post first dose.
Number of Participants Free of Gadolinium-Enhanced (GdE) Brain Lesions at Each Visit
Number of participants without gadolinium enhanced (GdE) brain MRI lesions at each visit. Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on cumulative number of GdE lesions at a participant level.
At baseline and every 12 months thereafter up until 72 months post first dose.
Number of Participants Free of New or Enlarging T2 Lesions at Each Visit
Number of participants without new or enlarging T2 brain MRI lesions at each visit. Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. The presence of new or larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Based on cumulative number of new or enlarging T2 lesions at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Percent Change in Normalized Brain Volume (Atrophy) on Brain MRI Scans From Baseline at Each Visit
Percent change in normalized brain volume (Atrophy) on brain MRI scans from baseline at each visit. Brain atrophy can be seen in the earliest stages of multiple sclerosis (MS) and is a reliable predictor of future physical and cognitive disability.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until approximately 87 months post first dose.
Change in Multiple Sclerosis Functional Composite (MSFC) Score From Baseline at Each Applicable Visit
The Multiple Sclerosis Functional Composite (MSFC) is a 3-part tool to measure disability progression in those with multiple sclerosis (MS). It assesses leg, arm, hand, and cognitive function using 3 individual scales: - The Timed 25-Foot Walk: To measure leg function - The 9-Hole Peg Test: To measure arm and hand function - The Symbol Digit Modalities Test (SDMT): To measure cognitive processing speed, flexibility, and calculation ability. Scores from each of the three are converted into Z-scores and averaged to create an overall composite score. The Low-Contrast Letter Acuity Test (LCLA) is performed with the MSFC using a set of charts to assess low contrast visual acuity. Each chart corresponds to a different contrast level, and charts are scored based on the number of letters identified correctly. A Z-score of 0 represents the population mean. Standard deviations above the mean represent a better outcome. Baseline refers to assessments on or before receiving study treatment.
At baseline and every 12 months thereafter up until 84 months post first dose.
Change in Multiple Sclerosis Quality of Life 54 Score From Baseline at Each Applicable Visit
The Multiple Sclerosis Quality of Life 54 (MSQOL-54) questionnaire is a health-related quality of life (HRQOL) instrument specific for multiple sclerosis (MS). This 54-item instrument generates 12 subscales along with two summary scores (physical health and mental health - derived from a weighted combination of scale scores), and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The MSQOL-54 items are transformed to 0-100 scores, and final scores are obtained by averaging items within the scales. The overall quality of life is assessed in question 54, which is scored on a scale of 0-100. Higher scores indicate better health-related quality of life. Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 84 months post first dose.
Change From Baseline in Volume of Gadolinium Enhanced T1 Lesions
Change from baseline in volume of gadolinium enhanced T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Change From Baseline in Volume of T2 Lesions
Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. Larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Change From Baseline in Volume of Unenhancing T1 Lesions
Change from baseline in volume of unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Cumulative Number of New Unenhancing T1 Lesions
Number of new unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The appearance of new T1 lesions may mean the participant's MS is progressing.
Derived as the cumulative number of new or enlarging T1 lesions relative to baseline at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
At baseline and every 12 months thereafter up until 72 months post first dose.
Phoenix
Arizona
85013
United States
Local Institution - 110
Berkeley
California
94705
United States
Local Institution - 103
Fresno
California
93710
United States
Local Institution - 122
Long Beach
California
90806
United States
Local Institution - 112
Sacramento
California
95817
United States
Local Institution - 120
San Francisco
California
94158
United States
Local Institution - 114
Maitland
Florida
32751
United States
Local Institution - 123
Port Charlotte
Florida
33952
United States
Local Institution - 124
Sunrise
Florida
33351
United States
Local Institution - 147
Tampa
Florida
33609
United States
Local Institution - 137
Golden Valley
Minnesota
55422
United States
Local Institution - 170
Las Vegas
Nevada
89106
United States
Local Institution - 143
Raleigh
North Carolina
27607
United States
Local Institution - 107
Westerville
Ohio
43801
United States
Local Institution - 144
Knoxville
Tennessee
37922
United States
Local Institution - 138
Lubbock
Texas
79410
United States
Local Institution - 179
Round Rock
Texas
78681
United States
Local Institution - 141
Kirkland
Washington
98034
United States
Local Institution - 907
Grodno
230017
Belarus
Local Institution - 904
Homyel
246029
Belarus
Local Institution - 902
Minsk
220026
Belarus
Local Institution - 901
Minsk
220114
Belarus
Local Institution - 903
Minsk
220116
Belarus
Local Institution - 905
Vitebsk
210023
Belarus
Local Institution - 906
Vitebsk
210037
Belarus
Local Institution - 256
Bruges
8000
Belgium
Local Institution - 255
Brussels
1200
Belgium
Local Institution - 252
Montegnée
4420
Belgium
Local Institution - 913
Banja Luka
51000
Bosnia and Herzegovina
Local Institution - 911
Sarajevo
71000
Bosnia and Herzegovina
Local Institution - 453
Sofia
1113
Bulgaria
Local Institution - 454
Sofia
1113
Bulgaria
Local Institution - 452
Sofia
1309
Bulgaria
Local Institution - 456
Sofia
1407
Bulgaria
Local Institution - 457
Sofia
1431
Bulgaria
Local Institution - 460
Sofia
1431
Bulgaria
Local Institution - 455
Sofia
1606
Bulgaria
Local Institution - 923
Osijek
31000
Croatia
Local Institution - 921
Zagreb
10000
Croatia
Local Institution - 922
Zagreb
10000
Croatia
Local Institution - 924
Zagreb
10000
Croatia
Local Institution - 473
Tallinn
10138
Estonia
Local Institution - 471
Tallinn
10617
Estonia
Local Institution - 472
Tartu
EE-51014
Estonia
Local Institution - 301
Tbilisi
0112
Georgia
Local Institution - 302
Tbilisi
0160
Georgia
Local Institution - 304
Tbilisi
0160
Georgia
Local Institution - 306
Tbilisi
0177
Georgia
Local Institution - 303
Tbilisi
0179
Georgia
Local Institution - 487
Leipzig
04103
Germany
Local Institution - 496
Potsdam
14471
Germany
Local Institution - 488
Ulm
89079
Germany
Local Institution - 552
Athens
10676
Greece
Local Institution - 553
Athens
115 21
Greece
Local Institution - 551
Athens
11525
Greece
Local Institution - 555
Thessaloniki
57010
Greece
Local Institution - 352
Budapest
1145
Hungary
Local Institution - 356
Budapest
1204
Hungary
Local Institution - 354
Esztergom
2500
Hungary
Local Institution - 358
Kistarcsa
2143
Hungary
Local Institution - 351
Nyíregyháza
4400
Hungary
Local Institution - 654
Catania
95123
Italy
Local Institution - 653
Cefalù
90015
Italy
Local Institution - 655
Milan
20122
Italy
Local Institution - 659
Montichiari
25018
Italy
Local Institution - 651
Roma
00133
Italy
Local Institution - 562
Riga
LV-1015
Latvia
Local Institution - 561
Riga
LV1002
Latvia
Local Institution - 622
Kaunas
Kaunas County
LT-50009
Lithuania
Local Institution - 621
Klaipėda
LT-92288
Lithuania
Local Institution - 932
Chisinau
2004
Moldova
Local Institution - 931
Chisinau
2028
Moldova
Local Institution - 933
Chisinau
2028
Moldova
Local Institution - 511
Christchurch
8011
New Zealand
Local Institution - 510
Hamilton
2001
New Zealand
Local Institution - 434
Warsaw
Masovian Voivodeship
05-077
Poland
Local Institution - 401
Bialystok
15-420
Poland
Local Institution - 423
Bydgoszcz
85-795
Poland
Local Institution - 406
Czeladź
41-250
Poland
Local Institution - 405
Gdansk
80-803
Poland
Local Institution - 432
Jarosław
37-500
Poland
Local Institution - 417
Katowice
40-555
Poland
Local Institution - 427
Katowice
40-595
Poland
Local Institution - 426
Katowice
40-650
Poland
Local Institution - 407
Katowice
40-749
Poland
Local Institution - 424
Kielce
25-726
Poland
Local Institution - 404
Konstancin-Jeziorna
05-510
Poland
Local Institution - 414
Krakow
31-305
Poland
Local Institution - 411
Lódzkie
90-324
Poland
Local Institution - 429
Lublin
20-059
Poland
Local Institution - 412
Lublin
20-718
Poland
Local Institution - 420
Lublin
20-718
Poland
Local Institution - 431
Mazowieckie
02-097
Poland
Local Institution - 415
Olsztyn
10-561
Poland
Local Institution - 421
Plewiska
62-064
Poland
Local Institution - 425
Pomorskie
80-299
Poland
Local Institution - 408
Poznan
60-355
Poland
Local Institution - 418
Poznan
61-853
Poland
Local Institution - 433
Rybnik
44-200
Poland
Local Institution - 435
Rzeszów
35-326
Poland
Local Institution - 419
Szczecin
70-111
Poland
Local Institution - 402
Warminsko-mazurskie
10-443
Poland
Local Institution - 410
Warsaw
00-739
Poland
Local Institution - 428
Warsaw
01-697
Poland
Local Institution - 422
Warsaw
02-507
Poland
Local Institution - 403
Warsaw
02-957
Poland
Local Institution - 413
Warsaw
04-141
Poland
Local Institution - 772
Braga
4710-243
Portugal
Local Institution - 775
Coimbra
3000-075
Portugal
Local Institution - 773
Torres Vedras
2560-280
Portugal
Local Institution - 503
Brasov
500123
Romania
Local Institution - 509
Bucharest
022328
Romania
Local Institution - 504
Bucharest
20125
Romania
Local Institution - 520
Bucharest
20125
Romania
Local Institution - 502
Campulung Muscel
115100
Romania
Local Institution - 508
Cluj-Napoca
400012
Romania
Local Institution - 501
Cluj-Napoca
400347
Romania
Local Institution - 507
Constanța
900123
Romania
Local Institution - 506
Timișoara
300736
Romania
Local Institution - 602
Belgrade
11000
Serbia
Local Institution - 603
Belgrade
11000
Serbia
Local Institution - 604
Belgrade
11000
Serbia
Local Institution - 601
Belgrade
11080
Serbia
Local Institution - 605
Kragujevac
34000
Serbia
Local Institution - 606
Niš
18000
Serbia
Local Institution - 946
Bratislava
833 05
Slovakia
Local Institution - 942
Lučenec
984 01
Slovakia
Local Institution - 945
Trnava
91775
Slovakia
Local Institution - 953
Pretoria
0040
South Africa
Local Institution - 756
Barcelona
08003
Spain
Local Institution - 758
Barcelona
08035
Spain
Local Institution - 761
Bilbao
48013
Spain
Local Institution - 759
Donostia / San Sebastian
20014
Spain
Local Institution - 760
Girona
17190
Spain
Local Institution - 757
Madrid
28006
Spain
Local Institution - 754
Majadahonda
28222
Spain
Local Institution - 764
Pamplona/ Navarra
31008
Spain
Local Institution - 766
Sant Joan Despí
08970
Spain
Local Institution - 755
Sevillla
41009
Spain
Local Institution - 767
Valencia
46010
Spain
Local Institution - 752
Valencia
46026
Spain
Local Institution - 780
Gothenburg
SE-413 45
Sweden
Local Institution - 823
Cherkasy
18009
Ukraine
Local Institution - 830
Chernihiv
14001
Ukraine
Local Institution - 805
Chernihiv
14029
Ukraine
Local Institution - 813
Chernivtsi
58018
Ukraine
Local Institution - 802
Dnipropetrovsk
49027
Ukraine
Local Institution - 815
Dnipropetrovsk
49027
Ukraine
Local Institution - 801
Ivano-Frankivsk
76008
Ukraine
Local Institution - 829
Ivano-Frankivsk
76018
Ukraine
Local Institution - 814
Kharkiv
61018
Ukraine
Local Institution - 827
Kharkiv
61022
Ukraine
Local Institution - 832
Kharkiv
61176
Ukraine
Local Institution - 811
Kherson
73000
Ukraine
Local Institution - 822
Kyiv
03115
Ukraine
Local Institution - 803
Kyiv
04107
Ukraine
Local Institution - 818
Kyiv
3110
Ukraine
Local Institution - 824
Kyiv
3110
Ukraine
Local Institution - 817
Lutsk
43024
Ukraine
Local Institution - 812
Lviv
79010
Ukraine
Local Institution - 821
Lviv
79044
Ukraine
Local Institution - 810
Odesa
65009
Ukraine
Local Institution - 831
Odesa
65025
Ukraine
Local Institution - 804
Odesa
65117
Ukraine
Local Institution - 826
Poltava
36011
Ukraine
Local Institution - 820
Uzhhorod
88018
Ukraine
Local Institution - 809
Vinnytsia
21005
Ukraine
Local Institution - 825
Zaporizhia
69065
Ukraine
Local Institution - 828
Zaporizhzhia
69600
Ukraine
Local Institution - 806
Zaporizhzhya
69035
Ukraine
Local Institution - 819
Zhytomyr
10008
Ukraine
Local Institution - 965
East Sussex
BN2 5BE
United Kingdom
Local Institution - 963
Inverness
IV2 3UJ
United Kingdom
Local Institution - 964
Sheffield
S10 2JF
United Kingdom
Derived
Selmaj KW, Steinman L, Comi G, Bar-Or A, Arnold DL, Hartung HP, Montalban X, Havrdova EK, Sheffield JK, Krakovich A, Cheng CY, Riolo JV, Pachai C, Thorpe A, DeBoer E, Kappos L, Cohen JA, Cree BA. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial. Mult Scler. 2025 Nov;31(13):1557-1571. doi: 10.1177/13524585251382796. Epub 2025 Nov 5.
Cree BAC, Maddux R, Bar-Or A, Hartung HP, Kaur A, Brown E, Li Y, Hu Y, Sheffield JK, Silva D, Harris S. SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis. Ann Clin Transl Neurol. 2023 Oct;10(10):1725-1737. doi: 10.1002/acn3.51862. Epub 2023 Aug 7.
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
FG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
FG000740 subjects
FG001875 subjects
FG002879 subjects
Transferred From IFN β-1a Parent Group
FG0000 subjects
FG0013 subjectsParticipants were planned for IFN β-1a received RPC1063 0.5 mg
FG0021 subjectsParticipant was planned for IFN β 1a but received RPC1063 1 mg
Transferred From RPC1063 0.5 mg Parent Group
FG0000 subjects
FG0010 subjects
FG0021 subjectsParticipant was planned for RPC1063 0.5 mg but received RPC1063 1 mg
Randomized to Placebo in the Parent Study
FG0000 subjects
FG00137 subjects
FG00235 subjects
Safety Population
Participants were included in the treatment group based on the treatment that they actually received in the parent study.
FG000736 subjects
FG001877 subjects
FG002881 subjects
COMPLETED
FG000564 subjects
FG001691 subjects
FG002695 subjects
NOT COMPLETED
FG000176 subjects
FG001184 subjects
FG002184 subjects
Type
Comment
Reasons
Other Reasons
FG00016 subjects
FG00118 subjects
FG00215 subjects
Covid-19 Pandemic
FG0000 subjects
FG0011 subjects
FG0021 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
Physician Decision
FG0003 subjects
FG0018 subjects
FG0029 subjects
Participant Voluntarily Withdrew from Study
FG00091 subjects
FG00182 subjects
FG00285 subjects
Death
FG0003 subjects
FG0015 subjects
FG0023 subjects
Lost to Follow-up
FG0009 subjects
FG00110 subjects
FG00219 subjects
Protocol Violation
FG0004 subjects
FG0010 subjects
FG0025 subjects
Lack of Efficacy
FG00024 subjects
FG00128 subjects
FG00220 subjects
Adverse Event
FG00026 subjects
FG00132 subjects
FG00226 subjects
Demographics were summarized using the safety population - all participants enrolled in study RPC01-3001 who received at least one dose of open-label RPC1063.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
BG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
BG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000736
BG001877
BG002881
BG0032494
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000498
BG001595
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0018
BG002
Race/Ethnicity, Customized
Race
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG000734
BG001865
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
All treated participants
Posted
Count of Participants
Participants
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG000668
OG001775
OG002776
Primary
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
All treated participants
Posted
Count of Participants
Participants
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
All treated participants
Posted
Count of Participants
Participants
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
All treated participants
Posted
Count of Participants
Participants
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants Experiencing Adverse Events (AEs) of Special Interest
An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product.
All treated participants
Posted
Count of Participants
Participants
From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC)
An absolute lymphocyte count (ALC) is a part of a blood test that measures the number of lymphocytes, a type of white blood cell, in the blood. Lymphocytes help fight infections and diseases. Reductions in ALC levels for participants in this study is expected and is a primary pharmacodynamic effect of RPC1063.
LLN = Lower limit of normal
All treated participants with at least one on treatment ALC assessment
Posted
Count of Participants
Participants
From first dose up until last dose of study treatment (up to approximately 82 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants With Abnormalities in White Blood Cell Count (WBC)
A white blood cell count is a part of a blood test that measures the number of white blood cells in the blood. White blood cells help fight infections and diseases.
LLN = Lower limit of normal
All treated participants with at least one on treatment WBC assessment
Posted
Count of Participants
Participants
From first dose up until last dose of study treatment (up to approximately 82 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Primary
Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC)
An absolute neutrophil count is a part of a blood test that measures the number of neutrophils, a type of white blood cell, in the blood. Neutrophils help fight infections and diseases.
All treated participants with at least one on treatment ANC assessment
Posted
Count of Participants
Participants
From first dose up until last dose of study treatment (up to approximately 82 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Primary
Number of Participants With Abnormalities in Specific Liver Function Tests
The number of participants with laboratory abnormalities in specific liver tests above ULN by category. ULN = Upper Limit of Normal
All treated participants with at least one on treatment liver function test
Posted
Count of Participants
Participants
From first dose up until last dose of study treatment (up to approximately 82 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Primary
Number of Participants With Electrocardiogram (ECG) Result Abnormalities
An electrocardiogram (ECG) measures electrical activity of the heart to detect cardiac problems.
All treated participants with baseline and at least one post baseline ECG assessment
Posted
Count of Participants
Participants
From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Primary
Number of Participants With Clinically Relevant Abnormalities in Vital Signs
Vital signs included body temperature, sitting heart rate/pulse (HR), sitting systolic blood pressure (SBP), sitting diastolic blood pressure (DBP).
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and on study assessment for that vital sign at 60 months post first dose
Posted
Count of Participants
Participants
At baseline and 60 months after first dose of study therapy
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Primary
Number of Participants With Physical Examination Abnormalities
The number of participants with abnormal physical examination results. The assessments included abdominal, extremity, head, heart, lungs, neck, neurological non-MS, other and skin assessments.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment physical assessment.
Posted
Count of Participants
Participants
At baseline and every 12 months thereafter up until 84 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide). Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with an assessment
Posted
Count of Participants
Participants
At baseline and every 3 months thereafter up until 78 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Primary
Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs.
Results are displayed as the number of participants who answered "Yes" to at least one of the 10 questions in the suicidal ideation or suicidal behavior section.
Ideation from 1 (wishing to be dead) - 5 (Active suicidal ideation with specific plan and intent) Behavior from 6 (Preparatory acts or behavior) - 10 (Completed suicide).
All treated participants who discontinued study treatment and had at least one on study and one post-dose assessment. Prespecified to be collected in combination for all three study arms.
Posted
Count of Participants
Participants
1, 4, 7, 14, 21, 28, and 90 days post last dose.
ID
Title
Description
OG000
Combined Parent Treatment Group
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment
The PWC-20 is a rater-administered 20-item scale to assess signs and symptoms of withdrawal. Twenty items are rated on a 4-point scale as not present (0 points), mild (1 point), moderate (2 points), or severe (3 points). The points from all items are calculated as a total score. Higher scores indicate more severe withdrawal symptoms.
All treated participants who discontinued study treatment and had at least one on study and one post-dose assessment. Prespecified to be collected in combination for all three study arms.
Posted
Mean
Standard Deviation
Change in Score on a Scale
1, 4, 7, 14, 21, and 90 days post last dose.
ID
Title
Description
OG000
Combined Parent Treatment Group
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000
Primary
Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment
The HADS is a validated patient reported outcome for assessing anxiety and depression. It consists of 14 items in total, 7 items related to anxiety and 7 items related to depression. For each item patients select a statement (valued at 0 to 3 points) that closest matches their own feeling over the past week. Separate total scores for anxiety and depression are derived by adding up points. Total scores can range from 0 to 21 points. Higher scores indicate more severe anxiety and depression and scores of 8 to 10 are generally considered indicative of borderline anxiety/depression disorders and scores of 11 and higher are generally considered indicative of anxiety/depression disorders.
All treated participants who discontinued study treatment and had at least one on study and one post-dose assessment. Prespecified to be collected in combination for all three study arms.
Posted
Mean
Standard Deviation
Change in Score on a Scale
1, 4, 7, 14, 21, and 90 days post last dose.
ID
Title
Description
OG000
Combined Parent Treatment Group
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Primary
Changes in Epworth Sleepiness Scale (ESS) Score From Last Day on Treatment
The ESS is a validated self administered questionnaire with 8 questions. Respondents rate on a 4-point scale (0 to 3) their chances of dozing off or falling asleep while engaged in 8 different activities. The ESS score is the sum of 8 item scores and can range from 0 to 24 points. Higher scores indicate more daytime sleepiness.
All treated participants who discontinued study treatment and had at least one on study and one post-dose assessment. Prespecified to be collected in combination for all three study arms.
Posted
Mean
Standard Deviation
Change in Score on a Scale
1, 4, 7, 14, 21, and 90 days post last dose.
ID
Title
Description
OG000
Combined Parent Treatment Group
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000
Primary
Changes in Vital Sign Values From Last Day on Treatment
All treated participants who discontinued study treatment and had at least one on study and one post-dose assessment. Prespecified to be collected in combination for all three study arms.
Posted
Mean
Standard Deviation
mmHg
1, 4, 7, 14, 21, 28, and 90 days post last dose.
ID
Title
Description
OG000
Combined Parent Treatment Group
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000
Secondary
Annualized Relapse Rate (ARR)
The Annualized Relapse Rate (ARR) is the average number of relapses per study arm in one year. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days. The adjusted ARR was based on the negative binomial regression model with parent treatment group, adjusted for region (Eastern Europe vs Rest of World), age at parent baseline, and the parent baseline number of gadolinium-enhanced (GdE) lesions. The natural log transformation of time on treatment was used as an offset term to adjust for participants having different exposure times.
All treated participants
Posted
Median
95% Confidence Interval
Proportion of participants
From first dose up until last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Time to First Relapse (TFR)
The time between first dose of study treatment and first relapse if experienced by a participant. A participant was censored if follow-up ended before a relapse occurred, whether due to the participant completing study, withdrawing from the study, or due to the cutoff of data collection for the analysis. The censor date was the date of the end of study or the date of the data cutoff for participant who were ongoing. Participants who withdrew from the study after the baseline visit were censored at the last known date while on study. Based on Kaplan-Meier product limit estimates.
All treated participants with confirmed relapse.
Posted
Median
95% Confidence Interval
Days
Overall: From first dose to first relapse, last dose, or data-cutoff date, whichever occurred first (up to approx 87 months); Visits: 2 weeks post first dose, 3 months post first dose, and every 3 months thereafter up until 81 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Number of Participants Who Were Relapse Free
The number of participants who did not experience relapse. A relapse is defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
All treated participants
Posted
Count of Participants
Participants
From first dose to last dose of study treatment or data-cutoff date, whichever occurred first (up to approximately 87 months)
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Secondary
Average Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions Per Scan at Each Visit
Adjusted Mean of new enlarging T2 lesions per scan at each visit. Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and baseline number of GdE lesions.
T2 Magnetic Resonance Imaging (MRI) sequences are used to highlight areas of demyelination in brain neurons, which happens when the outer layer of the neurons is damaged due to multiple sclerosis (MS) activity. T2 sequences can be used to count the total number of MS lesions, which look like bright white spots on T2 sequences, and can be called "hyperintense".
All treated participants with at least one on treatment MRI assessment showing new or enlarging lesions.
Posted
Mean
95% Confidence Interval
New or Enlarging Lesions per Scan
At 12 months post first dose and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Average Number of Gadolinium-Enhanced (GdE) Brain MRI Lesions Per Scan at Each Visit
Number of gadolinium-enhanced (GdE) (also called GdE enhanced T1) brain MRI lesions per scan at each visit.
Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on a negative binomial regression model, adjusted for parent study, region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment showing the presence of GdE brain MRI lesions.
Posted
Mean
95% Confidence Interval
New or Enlarging Lesions
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Time to Onset of Disability Progression as Defined by a Sustained Worsening in Expanded Disability Status Scale (EDSS)
Multiple sclerosis (MS) disability progression is defined as a sustained worsening in EDSS of 1.0 points or more from baseline, confirmed after a 3-month and 6-month period. The EDSS is a standardized method, widely accepted, numerical scale used to evaluate disability in people with multiple sclerosis (MS). The EDSS is evaluated according to signs and symptoms observed during a standard neurological examination. These clinical observations are classified in 7 FS scales, each of them grading signs and symptoms for different neurological functions: pyramidal, cerebellar, brainstem, sensory, bowel or bladder, visual, and cerebral.
Derived using Kaplan-Meier estimates.
All treated participants with disability progression data
Posted
Median
95% Confidence Interval
Days
At 3 and 6 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Number of Participants Free of Gadolinium-Enhanced (GdE) Brain Lesions at Each Visit
Number of participants without gadolinium enhanced (GdE) brain MRI lesions at each visit. Increased numbers of GdE lesions indicates an increase in the in the amount of active inflammation at the site and may be indicative of progressive disease.
Based on cumulative number of GdE lesions at a participant level.
All participants in the intent to treat (ITT) population with baseline and at least one on treatment MRI assessment showing the absence of GdE brain lesions.
Posted
Count of Participants
Participants
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Number of Participants Free of New or Enlarging T2 Lesions at Each Visit
Number of participants without new or enlarging T2 brain MRI lesions at each visit. Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. The presence of new or larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Based on cumulative number of new or enlarging T2 lesions at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
All participants in the intent to treat population with baseline and at least one on treatment MRI assessment for T2 hyperintense lesions.
Posted
Count of Participants
Participants
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Percent Change in Normalized Brain Volume (Atrophy) on Brain MRI Scans From Baseline at Each Visit
Percent change in normalized brain volume (Atrophy) on brain MRI scans from baseline at each visit. Brain atrophy can be seen in the earliest stages of multiple sclerosis (MS) and is a reliable predictor of future physical and cognitive disability.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment.
Posted
Mean
Standard Deviation
Percent Volume Change from Baseline
At baseline and every 12 months thereafter up until approximately 87 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Change in Multiple Sclerosis Functional Composite (MSFC) Score From Baseline at Each Applicable Visit
The Multiple Sclerosis Functional Composite (MSFC) is a 3-part tool to measure disability progression in those with multiple sclerosis (MS). It assesses leg, arm, hand, and cognitive function using 3 individual scales: - The Timed 25-Foot Walk: To measure leg function - The 9-Hole Peg Test: To measure arm and hand function - The Symbol Digit Modalities Test (SDMT): To measure cognitive processing speed, flexibility, and calculation ability. Scores from each of the three are converted into Z-scores and averaged to create an overall composite score. The Low-Contrast Letter Acuity Test (LCLA) is performed with the MSFC using a set of charts to assess low contrast visual acuity. Each chart corresponds to a different contrast level, and charts are scored based on the number of letters identified correctly. A Z-score of 0 represents the population mean. Standard deviations above the mean represent a better outcome. Baseline refers to assessments on or before receiving study treatment.
All treated participants with baseline and non-baseline MSFC Z-score assessments for the respective visit
Posted
Mean
Standard Deviation
Z-Score
At baseline and every 12 months thereafter up until 84 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Change in Multiple Sclerosis Quality of Life 54 Score From Baseline at Each Applicable Visit
The Multiple Sclerosis Quality of Life 54 (MSQOL-54) questionnaire is a health-related quality of life (HRQOL) instrument specific for multiple sclerosis (MS). This 54-item instrument generates 12 subscales along with two summary scores (physical health and mental health - derived from a weighted combination of scale scores), and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The MSQOL-54 items are transformed to 0-100 scores, and final scores are obtained by averaging items within the scales. The overall quality of life is assessed in question 54, which is scored on a scale of 0-100. Higher scores indicate better health-related quality of life. Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and non-baseline MSQOL-54 scores for the respective visit
Posted
Mean
Standard Deviation
Scores on a Scale
At baseline and every 12 months thereafter up until 84 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Change From Baseline in Volume of Gadolinium Enhanced T1 Lesions
Change from baseline in volume of gadolinium enhanced T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment showing the presence of brain MRI lesions.
Posted
Mean
Standard Deviation
Volume (cm^3) Change from Baseline
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Change From Baseline in Volume of T2 Lesions
Some multiple Sclerosis (MS) lesions appear as bright spots in a T2-weighted MRI scan - these are called T2 lesions. Larger T2 lesions may mean the participant is at higher risk of disability and may have a less favorable long-term outcome.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment showing the presence of brain MRI lesions.
Posted
Mean
Standard Deviation
Volume (cm^3) Change from Baseline
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Change From Baseline in Volume of Unenhancing T1 Lesions
Change from baseline in volume of unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The growth of T1 lesions may mean the participant's Multiple Sclerosis (MS) is progressing.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment showing the presence of brain MRI lesions.
Posted
Mean
Standard Deviation
Volume (cm^3) Change from Baseline
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Secondary
Cumulative Number of New Unenhancing T1 Lesions
Number of new unenhancing T1 lesions. T1-lesions are permanently damaged areas of the brain that appear as dark spots or "black holes" on a type of MRI scan. The appearance of new T1 lesions may mean the participant's MS is progressing.
Derived as the cumulative number of new or enlarging T1 lesions relative to baseline at a participant level.
Baseline refers to assessments made on or before the first day participants received study treatment.
All treated participants with baseline and at least one on treatment MRI assessment showing new or enlarging lesions.
Posted
Mean
Standard Deviation
New or Enlarging Lesions.
At baseline and every 12 months thereafter up until 72 months post first dose.
ID
Title
Description
OG000
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Time Frame
All-Cause Mortality was assessed from first dose until study completion (assessed up to approximately 87 months). SAEs and Other AEs were assessed from first dose to 90-days post last dose (an average of 65 months up to a max of 85 months).
Description
The placebo 0.5 mg, placebo 1 mg, IFN-B-1a and RPC1063 0.5 mg and 1 mg parent groups were used to represent All-Cause Mortality, Serious Adverse Events and Other (Not Serious) Adverse Events.
Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
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
Parent Treatment Group: Placebo for RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063 to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
0
37
7
37
27
37
EG001
Parent Treatment Group: Placebo for RPC1063 1 mg
Participants received a 7-day titration regimen of RPC1063 to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
0
35
3
35
26
35
EG002
Parent Treatment Group IFN-B-1a 30 ug
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
6
736
108
736
598
736
EG003
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
5
840
132
840
663
840
EG004
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
5
846
131
846
659
846
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG0031 affected840 at risk
EG0040 affected846 at risk
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Adams-Stokes syndrome
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Sinoatrial block
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Kidney duplex
Congenital, familial and genetic disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Sebaceous naevus
Congenital, familial and genetic disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Otosclerosis
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Goitre
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hyperadrenocorticism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Blepharal pigmentation
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cataract
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Choroiditis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Uveitis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Visual impairment
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0011 affected35 at risk
EG0020 affected736 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Duodenal polyp
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Functional gastrointestinal disorder
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastric disorder
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Inflammatory bowel disease
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Ranula
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Sudden death
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Swelling face
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Biliary polyp
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0011 affected35 at risk
EG0020 affected736 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Chronic hepatitis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Abdominal wall infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0023 affected736 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0024 affected736 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0024 affected736 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Chronic hepatitis B
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Dacryocystitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Echinococciasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Endometritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastroenteritis staphylococcal
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
HIV infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Injection site abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0011 affected35 at risk
EG0020 affected736 at risk
EG003
Measles
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Orchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0023 affected736 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0024 affected736 at risk
EG003
Pyelonephritis chronic
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Salpingitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Salpingo-oophoritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Toxic shock syndrome
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Foreign body in gastrointestinal tract
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Nerve injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pulmonary contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0023 affected736 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Bursal fluid accumulation
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Chondromalacia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Connective tissue disorder
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0023 affected736 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Mandibular mass
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Angiomyxoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Bladder papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Borderline serous tumour of ovary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Colorectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Dermatofibrosarcoma protuberans
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Myxoid liposarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Nephroblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0011 affected35 at risk
EG0020 affected736 at risk
EG003
Neurilemmoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Ovarian germ cell teratoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Seminoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Squamous cell carcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0026 affected736 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Epilepsia partialis continua
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Neurological decompensation
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Noninfective encephalitis
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Anembryonic gestation
Pregnancy, puerperium and perinatal conditions
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Needle issue
Product Issues
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Acute stress disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Adjustment disorder with mixed anxiety and depressed mood
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cardiovascular somatic symptom disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Kidney hypermobility
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Urogenital fistula
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Adnexa uteri cyst
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Breast dysplasia
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Cervix disorder
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hydrosalpinx
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Menometrorrhagia
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Perineal fistula
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Polycystic ovaries
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Rectocele
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Reproductive tract disorder
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Varicocele
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Miscarriage of partner
Social circumstances
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Medical device removal
Surgical and medical procedures
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG0020 affected736 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG0021 affected736 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0004 affected37 at risk
EG0014 affected35 at risk
EG00228 affected736 at risk
EG00331 affected840 at risk
EG00436 affected846 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected37 at risk
EG0016 affected35 at risk
EG00283 affected736 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG0026 affected736 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG00213 affected736 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0014 affected35 at risk
EG00221 affected736 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0012 affected35 at risk
EG00215 affected736 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0010 affected35 at risk
EG0028 affected736 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0013 affected35 at risk
EG0025 affected736 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0013 affected35 at risk
EG00217 affected736 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG0025 affected736 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0013 affected35 at risk
EG00238 affected736 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0008 affected37 at risk
EG0017 affected35 at risk
EG002116 affected736 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0012 affected35 at risk
EG00213 affected736 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0014 affected35 at risk
EG00224 affected736 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0005 affected37 at risk
EG0019 affected35 at risk
EG002164 affected736 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0013 affected35 at risk
EG00230 affected736 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0011 affected35 at risk
EG00253 affected736 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0010 affected35 at risk
EG00246 affected736 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0010 affected35 at risk
EG00237 affected736 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0005 affected37 at risk
EG0018 affected35 at risk
EG00299 affected736 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0008 affected37 at risk
EG0013 affected35 at risk
EG00248 affected736 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0012 affected35 at risk
EG0027 affected736 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG00211 affected736 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0003 affected37 at risk
EG0013 affected35 at risk
EG00246 affected736 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0011 affected35 at risk
EG00223 affected736 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0014 affected35 at risk
EG0025 affected736 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG0024 affected736 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0014 affected35 at risk
EG00271 affected736 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG0021 affected736 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0007 affected37 at risk
EG0012 affected35 at risk
EG00268 affected736 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG00215 affected736 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0013 affected35 at risk
EG00232 affected736 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0013 affected35 at risk
EG00243 affected736 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0007 affected37 at risk
EG0016 affected35 at risk
EG00272 affected736 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0013 affected35 at risk
EG00226 affected736 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0011 affected35 at risk
EG0026 affected736 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0012 affected35 at risk
EG00211 affected736 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0017 affected35 at risk
EG002131 affected736 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG0023 affected736 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0012 affected35 at risk
EG00212 affected736 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0014 affected35 at risk
EG00228 affected736 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected37 at risk
EG0012 affected35 at risk
EG00238 affected736 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0010 affected35 at risk
EG0022 affected736 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0011 affected35 at risk
EG0026 affected736 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0010 affected35 at risk
EG00218 affected736 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected37 at risk
EG0010 affected35 at risk
EG0025 affected736 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected37 at risk
EG0012 affected35 at risk
EG0021 affected736 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0005 affected37 at risk
EG0012 affected35 at risk
EG00276 affected736 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG000108
OG001139
OG002134
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG00035
OG00135
OG00228
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG00032
OG00135
OG00228
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Infections and infestations
Title
Measurements
OG00019
OG00126
OG00219
Neoplasms benign, malignant and unspecified (Incl cysts and polyps)
Title
Measurements
OG0009
OG00114
OG00216
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0010
OG0021
Nervous system disorders
Title
Measurements
OG0000
OG0012
OG0021
Eye disorders
Title
Measurements
OG0005
OG0012
OG0022
Cardiac disorders
Title
Measurements
OG0000
OG0011
OG0022
Hepatobiliary disorders
Title
Measurements
OG0000
OG0011
OG0020
Skin and subcutaneous tissue disorders
Title
Measurements
OG0000
OG0010
OG0021
Congenital, familial and genetic disorders
Title
Measurements
OG0001
OG0010
OG0020
Investigations
Title
Measurements
OG00015
OG00114
OG0028
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000727
OG001868
OG002877
Title
Denominators
Categories
ALC < 0.2 x 10^9/L
Title
Measurements
OG00033
OG00133
OG00227
ALC < 0.5 x 10^9/L
Title
Measurements
OG000265
OG001323
OG002339
ALC < 0.8 x 10^9/L
Title
Measurements
OG000497
OG001620
OG002616
ALC < LLN
Title
Measurements
OG000592
OG001703
OG002704
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000727
OG001868
OG002877
Title
Denominators
Categories
Total WBC > 20 x 10^9/L
Title
Measurements
OG0000
OG0010
OG0022
Total WBC < 3 x 10^9/L
Title
Measurements
OG00027
OG00148
OG00243
Total WBC < 2 x 10^9/L
Title
Measurements
OG0000
OG0012
OG0020
Total WBC < 1 x 10^9/L
Title
Measurements
OG0000
OG0010
OG0020
Total WBC < LLN
Title
Measurements
OG00092
OG001107
OG002108
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000727
OG001868
OG002877
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000734
OG001875
OG002880
Title
Denominators
Categories
> 1 x ULN
Title
Measurements
OG000311
OG001353
OG002353
>= 2 x ULN
Title
Measurements
OG00090
OG001100
OG002107
>= 3 x ULN
Title
Measurements
OG00032
OG00130
OG00229
>= 4 x ULN
Title
Measurements
OG00016
OG00119
OG0026
>= 5 x ULN
Title
Measurements
OG0008
OG00112
OG0020
>= 10 x ULN
Title
Measurements
OG0004
OG0015
OG0020
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001876
OG002880
Title
Denominators
Categories
QT > 480 (ms)
Title
Measurements
OG0006
OG0015
OG0023
QT > 500 (ms)
Title
Measurements
OG0001
OG0010
OG0020
QTcF > 450 (ms)
Title
Measurements
OG00044
OG00149
OG00244
QTcF > 480 (ms)
Title
Measurements
OG0001
OG0015
OG0023
QTcF > 500 (ms)
Title
Measurements
OG0000
OG0010
OG0020
QTcB > 450 (ms)
Title
Measurements
OG000173
OG001186
OG002184
QTcB > 480 (ms)
Title
Measurements
OG0008
OG00115
OG00213
QTcB > 500 (ms)
Title
Measurements
OG0000
OG0012
OG0020
Change from Baseline in QTcF >30 ms
Title
Measurements
OG000134
OG001140
OG002120
Change from Baseline in QTcF >60 ms
Title
Measurements
OG0000
OG0015
OG0026
Change from Baseline in QTcB >30 ms
Title
Measurements
OG000183
OG001215
OG002205
Change from Baseline in QTcB >60 ms
Title
Measurements
OG0005
OG0019
OG00213
Atrial Ventricular Bock or Conduction Ratio, 2:1
Title
Measurements
OG0000
OG0010
OG0021
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000567
OG001715
OG002707
Title
Denominators
Categories
Temperature (C) >38.5 and an increase from Baseline of at least 1
ParticipantsOG000566
ParticipantsOG001715
ParticipantsOG002707
Title
Measurements
OG0000
OG0010
OG0020
Heart Rate (bpm) >120 beats per minute post-Baseline or an increase from Baseline of >20 bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Heart Rate (bpm) >120 bpm post-Baseline if Baseline <=120 bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Heart Rate (bpm) An increase from Baseline of more than 20 bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Heart Rate (bpm) <45 bpm post-Baseline or a decrease from Baseline of more than 20bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Heart Rate (bpm) <45 bpm post-Baseline if Baseline >=45 bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Heart Rate (bpm) A decrease from Baseline of more than 20 bpm
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002706
Title
Measurements
OG000
Systolic Blood Pressure (mmHg) >180 mmHg post-Baseline or an increase from Baseline of >40 mmHg
Diastolic Blood Pressure (mmHg) A decrease from Baseline of more than 30 mmHg
ParticipantsOG000567
ParticipantsOG001715
ParticipantsOG002707
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Baseline - Abdominal
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG0000
OG0010
OG0021
Baseline - Extremities
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Head
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Heart
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Lungs
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Neck
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Neurological-Non-MS
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Other
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Baseline - Skin
ParticipantsOG000736
ParticipantsOG001877
ParticipantsOG002881
Title
Measurements
OG000
Month 12 - Abdominal
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Extremities
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Head
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Heart
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Lungs
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Neck
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Neurological-Non-MS
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Other
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 12 - Skin
ParticipantsOG000708
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
Month 24 - Abdominal
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 -Extremities
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Head
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Lungs
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Neck
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Neurological-Non-MS
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Other
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 24 - Skin
ParticipantsOG000684
ParticipantsOG001811
ParticipantsOG002831
Title
Measurements
OG000
Month 36 - Abdominal
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Extremities
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Head
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Heart
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Lungs
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Neck
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Neurological-Non-MS
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Other
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 36 - Skin
ParticipantsOG000640
ParticipantsOG001774
ParticipantsOG002794
Title
Measurements
OG000
Month 48 - Abdominal
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Extremities
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Head
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Heart
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Lungs
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Neck
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Neurological-Non-MS
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Other
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 48 - Skin
ParticipantsOG000603
ParticipantsOG001736
ParticipantsOG002743
Title
Measurements
OG000
Month 60 - Abdominal
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Extremities
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Head
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Heart
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Lungs
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Neck
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Neurological-Non-MS
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Other
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 60 - Skin
ParticipantsOG000580
ParticipantsOG001717
ParticipantsOG002718
Title
Measurements
OG000
Month 72 - Abdominal
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Extremities
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Head
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Heart
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Lungs
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Neck
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Neurological-Non-MS
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Other
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 72 - Skin
ParticipantsOG000445
ParticipantsOG001564
ParticipantsOG002584
Title
Measurements
OG000
Month 84 - Abdominal
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG001
Month 84 - Extremities
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG001
Month 84 - Skin
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG001
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000733
OG001874
OG002879
Title
Denominators
Categories
At baseline (Suicidal Ideation or Behavior)
ParticipantsOG000393
ParticipantsOG001431
ParticipantsOG002417
Title
Measurements
OG0000
OG0012
OG0020
At month 3 (Suicidal Ideation or Behavior)
ParticipantsOG000733
ParticipantsOG001874
ParticipantsOG002879
Title
Measurements
OG000
At month 6 (Suicidal Ideation or Behavior)
ParticipantsOG000727
ParticipantsOG001865
ParticipantsOG002874
Title
Measurements
OG000
At month 9 (Suicidal Ideation or Behavior)
ParticipantsOG000719
ParticipantsOG001854
ParticipantsOG002860
Title
Measurements
OG000
At month 12 (Suicidal Ideation or Behavior)
ParticipantsOG000705
ParticipantsOG001848
ParticipantsOG002854
Title
Measurements
OG000
At month 15 (Suicidal Ideation or Behavior)
ParticipantsOG000698
ParticipantsOG001831
ParticipantsOG002847
Title
Measurements
OG000
At month 18 (Suicidal Ideation or Behavior)
ParticipantsOG000690
ParticipantsOG001822
ParticipantsOG002842
Title
Measurements
OG000
At month 21 (Suicidal Ideation or Behavior)
ParticipantsOG000682
ParticipantsOG001815
ParticipantsOG002833
Title
Measurements
OG000
At month 24 (Suicidal Ideation or Behavior)
ParticipantsOG000676
ParticipantsOG001800
ParticipantsOG002820
Title
Measurements
OG000
At month 27 (Suicidal Ideation or Behavior)
ParticipantsOG000663
ParticipantsOG001791
ParticipantsOG002812
Title
Measurements
OG000
At month 33 (Suicidal Ideation or Behavior)
ParticipantsOG000646
ParticipantsOG001780
ParticipantsOG002796
Title
Measurements
OG000
At month 36 (Suicidal Ideation or Behavior)
ParticipantsOG000631
ParticipantsOG001772
ParticipantsOG002787
Title
Measurements
OG000
At month 39 (Suicidal Ideation or Behavior)
ParticipantsOG000623
ParticipantsOG001761
ParticipantsOG002776
Title
Measurements
OG000
At month 42 (Suicidal Ideation or Behavior)
ParticipantsOG000611
ParticipantsOG001750
ParticipantsOG002755
Title
Measurements
OG000
At month 45 (Suicidal Ideation or Behavior)
ParticipantsOG000564
ParticipantsOG001704
ParticipantsOG002705
Title
Measurements
OG000
At month 48 (Suicidal Ideation or Behavior)
ParticipantsOG000606
ParticipantsOG001731
ParticipantsOG002740
Title
Measurements
OG000
At month 54 (Suicidal Ideation or Behavior)
ParticipantsOG000573
ParticipantsOG001714
ParticipantsOG002718
Title
Measurements
OG000
At month 57 (Suicidal Ideation or Behavior)
ParticipantsOG00040
ParticipantsOG00192
ParticipantsOG00290
Title
Measurements
OG000
At month 60 (Suicidal Ideation or Behavior)
ParticipantsOG000570
ParticipantsOG001716
ParticipantsOG002708
Title
Measurements
OG000
At month 66 (Suicidal Ideation or Behavior)
ParticipantsOG000538
ParticipantsOG001670
ParticipantsOG002677
Title
Measurements
OG000
At month 69 (Suicidal Ideation or Behavior)
ParticipantsOG000393
ParticipantsOG001419
ParticipantsOG002403
Title
Measurements
OG000
At month 72 (Suicidal Ideation or Behavior)
ParticipantsOG000267
ParticipantsOG001361
ParticipantsOG002352
Title
Measurements
OG000
At month 78 (Suicidal Ideation or Behavior)
ParticipantsOG0009
ParticipantsOG00165
ParticipantsOG00272
Title
Measurements
OG000
Units
Counts
Participants
OG000250
Title
Denominators
Categories
End of Treatment
ParticipantsOG000250
Title
Measurements
OG0003
Follow-up Visit Day 1
ParticipantsOG00096
Title
Measurements
OG0000
Follow-up Visit Day 4
ParticipantsOG00099
Title
Measurements
OG0000
Follow-up Visit Day 7
ParticipantsOG00099
Title
Measurements
OG0000
Follow-up Visit Day 14
ParticipantsOG00099
Title
Measurements
OG0000
Follow-up Visit Day 21
ParticipantsOG00091
Title
Measurements
OG0000
Safety Follow-up Visit (Day 28)
ParticipantsOG000219
Title
Measurements
OG0000
Follow-up Visit Day 90
ParticipantsOG000110
Title
Measurements
OG0000
95
Title
Denominators
Categories
End of Treatment
ParticipantsOG00072
Title
Measurements
OG000-0.1± 6.33
Follow-up Visit Day 1
ParticipantsOG00092
Title
Measurements
OG000-0.6± 5.06
Follow-up Visit Day 4
ParticipantsOG00092
Title
Measurements
OG000-0.5± 4.51
Follow-up Visit Day 7
ParticipantsOG00095
Title
Measurements
OG000-1.1± 4.33
Follow-up Visit Day 14
ParticipantsOG00090
Title
Measurements
OG000-0.4± 4.93
Follow-up Visit Day 21
ParticipantsOG00091
Title
Measurements
OG000-1.2± 5.31
Follow-up Visit Day 90
ParticipantsOG00095
Title
Measurements
OG000-0.7± 5.15
Units
Counts
Participants
OG00096
Title
Denominators
Categories
Depression - End of Treatment
ParticipantsOG00072
Title
Measurements
OG0000.3± 3.17
Depression - Follow-up Visit Day 1
ParticipantsOG00093
Title
Measurements
OG000-0.1± 2.15
Depression - Follow-up Visit Day 4
ParticipantsOG00094
Title
Measurements
OG000-0.1± 2.13
Depression - Follow-up Visit Day 7
ParticipantsOG00095
Title
Measurements
OG000-0.2± 2.29
Depression - Follow-up Visit Day 14
ParticipantsOG00091
Title
Measurements
OG0000.1± 2.36
Depression - Follow-up Visit Day 21
ParticipantsOG00093
Title
Measurements
OG0000.1± 2.35
Depression - 90-Day Safety Follow-up Visit
ParticipantsOG00096
Title
Measurements
OG000-0.2± 2.86
Anxiety - End of Treatment
ParticipantsOG00072
Title
Measurements
OG000-0.3± 2.76
Anxiety - Follow-up Visit Day 1
ParticipantsOG00093
Title
Measurements
OG000-0.5± 2.33
Anxiety - Follow-up Visit Day 4
ParticipantsOG00094
Title
Measurements
OG000-0.4± 2.30
Anxiety - Follow-up Visit Day 7
ParticipantsOG00095
Title
Measurements
OG000-0.8± 2.47
Anxiety - Follow-up Visit Day 14
ParticipantsOG00091
Title
Measurements
OG000-0.6± 2.17
Anxiety - Follow-up Visit Day 21
ParticipantsOG00093
Title
Measurements
OG000-0.7± 2.35
Anxiety - 90-Day Safety Follow-up Visit
ParticipantsOG00096
Title
Measurements
OG000-0.7± 2.99
96
Title
Denominators
Categories
End of Treatment
ParticipantsOG00073
Title
Measurements
OG0000.4± 4.92
Follow-up Visit Day 1
ParticipantsOG00093
Title
Measurements
OG000-0.6± 4.28
Follow-up Visit Day 4
ParticipantsOG00094
Title
Measurements
OG000-0.5± 4.38
Follow-up Visit Day 7
ParticipantsOG00095
Title
Measurements
OG000-0.7± 4.25
Follow-up Visit Day 14
ParticipantsOG00092
Title
Measurements
OG000-0.9± 4.10
Follow-up Visit Day 21
ParticipantsOG00093
Title
Measurements
OG000-0.9± 4.42
Follow-up Visit Day 90
ParticipantsOG00096
Title
Measurements
OG000-0.8± 3.75
252
Title
Denominators
Categories
Systolic Blood Pressure(mmHg)-Sitting: End of Treatment
ParticipantsOG000252
Title
Measurements
OG000-1.77± 11.189
Systolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 1
ParticipantsOG00049
Title
Measurements
OG0000.63± 8.311
Systolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 4
ParticipantsOG00052
Title
Measurements
OG000-0.04± 8.931
Systolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 7
ParticipantsOG00051
Title
Measurements
OG0000.82± 7.911
Systolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 14
ParticipantsOG00068
Title
Measurements
OG000-0.4± 8.128
Systolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 21
Diastolic Blood Pressure(mmHg)-Sitting: Follow-up Visit Day 90
ParticipantsOG00096
Title
Measurements
OG000-2.01± 7.689
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG0000.097(0.078 to 0.121)
OG0010.108(0.088 to 0.133)
OG0020.090(0.073 to 0.111)
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000223
OG001272
OG002276
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG001NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG002NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000736
OG001877
OG002881
Title
Denominators
Categories
Title
Measurements
OG000513
OG001605
OG002605
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000696
OG001722
OG002726
Title
Denominators
Categories
Month 12
ParticipantsOG000696
ParticipantsOG001722
ParticipantsOG002726
Title
Measurements
OG0001.532(1.309 to 1.792)
OG0011.163(0.995 to 1.360)
OG0021.302(1.116 to 1.519)
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000605
ParticipantsOG001643
ParticipantsOG002655
Title
Measurements
OG000
Month 48
ParticipantsOG000570
ParticipantsOG001585
ParticipantsOG002591
Title
Measurements
OG000
Month 60
ParticipantsOG000527
ParticipantsOG001575
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001162
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000740
OG001756
OG002760
Title
Denominators
Categories
Baseline
ParticipantsOG000740
ParticipantsOG001756
ParticipantsOG002760
Title
Measurements
OG0000.460(0.369 to 0.573)
OG0010.244(0.193 to 0.308)
OG0020.177(0.138 to 0.226)
Month 12
ParticipantsOG000695
ParticipantsOG001723
ParticipantsOG002725
Title
Measurements
OG000
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000604
ParticipantsOG001642
ParticipantsOG002653
Title
Measurements
OG000
Month 48
ParticipantsOG000569
ParticipantsOG001584
ParticipantsOG002590
Title
Measurements
OG000
Month 60
ParticipantsOG000525
ParticipantsOG001576
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001161
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000122
OG001160
OG002146
Title
Denominators
Categories
Month 3
ParticipantsOG000122
ParticipantsOG001160
ParticipantsOG002146
Title
Measurements
OG000NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG001NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG002NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
Month 6
ParticipantsOG000116
ParticipantsOG001135
ParticipantsOG002128
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000740
OG001756
OG002760
Title
Denominators
Categories
Baseline
ParticipantsOG000740
ParticipantsOG001756
ParticipantsOG002760
Title
Measurements
OG000538
OG001609
OG002662
Month 12
ParticipantsOG000695
ParticipantsOG001723
ParticipantsOG002725
Title
Measurements
OG000
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000604
ParticipantsOG001642
ParticipantsOG002653
Title
Measurements
OG000
Month 48
ParticipantsOG000569
ParticipantsOG001584
ParticipantsOG002590
Title
Measurements
OG000
Month 60
ParticipantsOG000525
ParticipantsOG001576
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001161
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000696
OG001722
OG002726
Title
Denominators
Categories
Month 12
ParticipantsOG000696
ParticipantsOG001722
ParticipantsOG002726
Title
Measurements
OG000322
OG001400
OG002419
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000605
ParticipantsOG001643
ParticipantsOG002655
Title
Measurements
OG000
Month 48
ParticipantsOG000570
ParticipantsOG001585
ParticipantsOG002591
Title
Measurements
OG000
Month 60
ParticipantsOG000527
ParticipantsOG001575
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001162
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000596
OG001611
OG002623
Title
Denominators
Categories
Month 12
ParticipantsOG000558
ParticipantsOG001573
ParticipantsOG002569
Title
Measurements
OG000-0.407± 0.731
OG001-0.359± 0.607
OG002-0.385± 0.602
Month 24
ParticipantsOG000480
ParticipantsOG001506
ParticipantsOG002515
Title
Measurements
OG000
Month 36
ParticipantsOG000410
ParticipantsOG001443
ParticipantsOG002454
Title
Measurements
OG000
Month 48
ParticipantsOG000392
ParticipantsOG001406
ParticipantsOG002416
Title
Measurements
OG000
Month 60
ParticipantsOG000341
ParticipantsOG001361
ParticipantsOG002375
Title
Measurements
OG000
Month 72
ParticipantsOG00069
ParticipantsOG00189
ParticipantsOG002103
Title
Measurements
OG000
End of Treatment
ParticipantsOG000596
ParticipantsOG001611
ParticipantsOG002623
Title
Measurements
OG000
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000702
OG001721
OG002732
Title
Denominators
Categories
MSFC Z Score Month 12
ParticipantsOG000702
ParticipantsOG001721
ParticipantsOG002732
Title
Measurements
OG0000.058± 2.540
OG001-0.085± 0.488
OG002-0.064± 0.618
MSFC Z Score Month 24
ParticipantsOG000679
ParticipantsOG001695
ParticipantsOG002711
Title
Measurements
OG000
MSFC Z Score Month 36
ParticipantsOG000636
ParticipantsOG001666
ParticipantsOG002677
Title
Measurements
OG000
MSFC Z Score Month 48
ParticipantsOG000594
ParticipantsOG001630
ParticipantsOG002633
Title
Measurements
OG000
MSFC Z Score Month 60
ParticipantsOG000573
ParticipantsOG001605
ParticipantsOG002609
Title
Measurements
OG000
MSFC Z Score Month 72
ParticipantsOG000433
ParticipantsOG001462
ParticipantsOG002483
Title
Measurements
OG000
MSFC Z Score Month 84
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
MSFC Z Score (LCLA) Month 12
ParticipantsOG000693
ParticipantsOG001709
ParticipantsOG002721
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 24
ParticipantsOG000668
ParticipantsOG001680
ParticipantsOG002705
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 36
ParticipantsOG000621
ParticipantsOG001649
ParticipantsOG002670
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 48
ParticipantsOG000583
ParticipantsOG001619
ParticipantsOG002627
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 60
ParticipantsOG000566
ParticipantsOG001595
ParticipantsOG002605
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 72
ParticipantsOG000424
ParticipantsOG001454
ParticipantsOG002477
Title
Measurements
OG000
MSFC Z Score (LCLA) Month 84
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
OG001
Parent Treatment Group: RPC1063 0.5 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000659
OG001678
OG002678
Title
Denominators
Categories
Month 12
ParticipantsOG000653
ParticipantsOG001678
ParticipantsOG002678
Title
Measurements
OG0000.1± 10.68
OG001-0.1± 10.55
OG0020.2± 9.85
Month 24
ParticipantsOG000659
ParticipantsOG001677
ParticipantsOG002678
Title
Measurements
OG000
Month 36
ParticipantsOG000622
ParticipantsOG001650
ParticipantsOG002649
Title
Measurements
OG000
Month 48
ParticipantsOG000585
ParticipantsOG001613
ParticipantsOG002609
Title
Measurements
OG000
Month 60
ParticipantsOG000553
ParticipantsOG001595
ParticipantsOG002582
Title
Measurements
OG000
Month 72
ParticipantsOG000445
ParticipantsOG001478
ParticipantsOG002478
Title
Measurements
OG000
Month 84
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000695
OG001723
OG002725
Title
Denominators
Categories
Month 12
ParticipantsOG000695
ParticipantsOG001723
ParticipantsOG002725
Title
Measurements
OG000-0.092± 0.435
OG001-0.015± 0.229
OG002-0.004± 0.180
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000604
ParticipantsOG001642
ParticipantsOG002653
Title
Measurements
OG000
Month 48
ParticipantsOG000569
ParticipantsOG001584
ParticipantsOG002590
Title
Measurements
OG000
Month 60
ParticipantsOG000525
ParticipantsOG001576
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001161
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000696
OG001723
OG002726
Title
Denominators
Categories
Month 12
ParticipantsOG000696
ParticipantsOG001723
ParticipantsOG002726
Title
Measurements
OG0000.190± 1.498
OG0010.174± 1.154
OG0020.278± 1.384
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000605
ParticipantsOG001643
ParticipantsOG002655
Title
Measurements
OG000
Month 48
ParticipantsOG000570
ParticipantsOG001585
ParticipantsOG002591
Title
Measurements
OG000
Month 60
ParticipantsOG000527
ParticipantsOG001575
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001162
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000695
OG001723
OG002726
Title
Denominators
Categories
Month 12
ParticipantsOG000695
ParticipantsOG001723
ParticipantsOG002726
Title
Measurements
OG000-0.625± 2.012
OG001-0.772± 1.792
OG002-0.760± 1.869
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002698
Title
Measurements
OG000
Month 36
ParticipantsOG000604
ParticipantsOG001643
ParticipantsOG002653
Title
Measurements
OG000
Month 48
ParticipantsOG000569
ParticipantsOG001584
ParticipantsOG002590
Title
Measurements
OG000
Month 60
ParticipantsOG000526
ParticipantsOG001575
ParticipantsOG002565
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001161
ParticipantsOG002164
Title
Measurements
OG000
OG002
Parent Treatment Group: RPC1063 1.0 mg
Participants received a 7-day titration regimen of RPC1063, as applicable to reach the targeted dose of 1.0 mg which was taken by mouth once per day until the end of the trial or until the Sponsor discontinued the development program. Participants were instructed to take RPC1063 at approximately the same time each day with or without food.
Units
Counts
Participants
OG000695
OG001722
OG002725
Title
Denominators
Categories
Month 12
ParticipantsOG000695
ParticipantsOG001722
ParticipantsOG002725
Title
Measurements
OG0001.9± 4.66
OG0011.1± 2.86
OG0021.2± 3.16
Month 24
ParticipantsOG000651
ParticipantsOG001683
ParticipantsOG002697
Title
Measurements
OG000
Month 36
ParticipantsOG000604
ParticipantsOG001642
ParticipantsOG002653
Title
Measurements
OG000
Month 48
ParticipantsOG000568
ParticipantsOG001584
ParticipantsOG002590
Title
Measurements
OG000
Month 60
ParticipantsOG000525
ParticipantsOG001574
ParticipantsOG002564
Title
Measurements
OG000
Month 72
ParticipantsOG000136
ParticipantsOG001161
ParticipantsOG002163
Title
Measurements
OG000
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0042 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0043 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
4 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
8 affected
840 at risk
EG0047 affected846 at risk
6 affected
840 at risk
EG00410 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
2 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0047 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
2 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
2 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
4 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
3 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0043 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
5 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
3 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0043 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
4 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0042 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
2 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
1 affected
840 at risk
EG0042 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0040 affected846 at risk
0 affected
840 at risk
EG0041 affected846 at risk
1 affected
840 at risk
EG0041 affected846 at risk
92 affected
840 at risk
EG00473 affected846 at risk
3 affected
840 at risk
EG0043 affected846 at risk
15 affected
840 at risk
EG00412 affected846 at risk
37 affected
840 at risk
EG00425 affected846 at risk
17 affected
840 at risk
EG00411 affected846 at risk
9 affected
840 at risk
EG0047 affected846 at risk
8 affected
840 at risk
EG0047 affected846 at risk
27 affected
840 at risk
EG00429 affected846 at risk
9 affected
840 at risk
EG0046 affected846 at risk
58 affected
840 at risk
EG00455 affected846 at risk
130 affected
840 at risk
EG004136 affected846 at risk
17 affected
840 at risk
EG00412 affected846 at risk
32 affected
840 at risk
EG00424 affected846 at risk
176 affected
840 at risk
EG004177 affected846 at risk
39 affected
840 at risk
EG00435 affected846 at risk
56 affected
840 at risk
EG00453 affected846 at risk
52 affected
840 at risk
EG00446 affected846 at risk
33 affected
840 at risk
EG00430 affected846 at risk
101 affected
840 at risk
EG00497 affected846 at risk
52 affected
840 at risk
EG00458 affected846 at risk
7 affected
840 at risk
EG0043 affected846 at risk
8 affected
840 at risk
EG00413 affected846 at risk
40 affected
840 at risk
EG00434 affected846 at risk
20 affected
840 at risk
EG00415 affected846 at risk
7 affected
840 at risk
EG0048 affected846 at risk
3 affected
840 at risk
EG0043 affected846 at risk
63 affected
840 at risk
EG00461 affected846 at risk
3 affected
840 at risk
EG0044 affected846 at risk
77 affected
840 at risk
EG00481 affected846 at risk
10 affected
840 at risk
EG00411 affected846 at risk
36 affected
840 at risk
EG00433 affected846 at risk
53 affected
840 at risk
EG00461 affected846 at risk
81 affected
840 at risk
EG00471 affected846 at risk
29 affected
840 at risk
EG00432 affected846 at risk
8 affected
840 at risk
EG00412 affected846 at risk
8 affected
840 at risk
EG0046 affected846 at risk
142 affected
840 at risk
EG004144 affected846 at risk
9 affected
840 at risk
EG00413 affected846 at risk
10 affected
840 at risk
EG00420 affected846 at risk
26 affected
840 at risk
EG00429 affected846 at risk
45 affected
840 at risk
EG00441 affected846 at risk
6 affected
840 at risk
EG0043 affected846 at risk
7 affected
840 at risk
EG0045 affected846 at risk
32 affected
840 at risk
EG00430 affected846 at risk
7 affected
840 at risk
EG0045 affected846 at risk
6 affected
840 at risk
EG0044 affected846 at risk
81 affected
840 at risk
EG00460 affected846 at risk
15
OG00119
OG00226
0
OG0010
OG0020
15
OG00119
OG00226
7
OG00112
OG0028
0
OG0010
OG0020
7
OG00112
OG0028
3
OG0015
OG0025
0
OG0010
OG0020
3
OG0015
OG0025
3
OG0011
OG0023
1
OG0010
OG0020
2
OG0011
OG0023
2
OG0014
OG0024
1
OG0012
OG0023
1
OG0012
OG0022
1
OG0012
OG0020
0
OG0010
OG0020
1
OG0012
OG0020
3
OG0012
OG0028
0
OG0011
OG0021
1
OG0010
OG0021
0
OG0011
OG0022
0
OG0011
OG0023
1
OG0011
OG0025
2
OG0016
OG0024
17
OG00117
OG00216
1
OG0012
OG0022
2
OG0014
OG0026
2
OG0012
OG0023
3
OG0010
OG0020
0
OG0010
OG0021
0
OG0011
OG0023
1
OG0013
OG0020
2
OG0014
OG0022
25
OG00124
OG00221
0
OG0012
OG0022
5
OG0019
OG0026
3
OG0014
OG0022
0
OG0011
OG0023
1
OG0011
OG0022
2
OG0011
OG0023
2
OG0013
OG0023
20
OG00121
OG00223
1
OG0011
OG0021
5
OG0015
OG0027
1
OG0010
OG0024
0
OG0010
OG0021
1
OG0012
OG0021
1
OG0011
OG0020
1
OG0011
OG0024
4
OG0014
OG0024
22
OG00132
OG00234
0
OG0010
OG0021
4
OG0017
OG0025
1
OG0012
OG0021
0
OG0010
OG0021
0
OG0011
OG0022
0
OG0011
OG0020
3
OG0011
OG0020
2
OG0013
OG0024
19
OG00123
OG00218
1
OG0012
OG0020
4
OG0019
OG00211
1
OG0011
OG0021
0
OG0010
OG0022
0
OG0011
OG0022
2
OG0010
OG0020
2
OG0011
OG0024
3
OG0014
OG0021
16
OG00128
OG00218
1
OG0012
OG0022
4
OG0015
OG0025
0
OG0011
OG0021
0
OG0010
OG0020
0
OG0010
OG0021
1
OG0010
OG0020
2
OG0012
OG0022
5
OG0013
OG0022
8
OG00119
OG00210
1
OG0020
1
OG0021
2
OG0020
2
OG0011
OG0021
1
OG0011
OG0022
3
OG0010
OG0021
3
OG0010
OG0022
0
OG0010
OG0021
1
OG0011
OG0022
1
OG0010
OG0021
1
OG0012
OG0021
0
OG0010
OG0020
1
OG0010
OG0020
2
OG0011
OG0020
0
OG0011
OG0020
0
OG0010
OG0021
0
OG0010
OG0020
2
OG0010
OG0021
1
OG0010
OG0021
0
OG0010
OG0020
2
OG0011
OG0021
1
OG0012
OG0021
1
OG0010
OG0021
1
OG0010
OG0021
0
OG0010
OG0021
1.254
(1.072 to 1.466)
OG0011.005(0.862 to 1.172)
OG0021.190(1.022 to 1.385)
1.136
(0.963 to 1.340)
OG0011.021(0.872 to 1.197)
OG0021.142(0.976 to 1.335)
0.935
(0.786 to 1.112)
OG0010.915(0.770 to 1.087)
OG0021.044(0.883 to 1.234)
0.791
(0.661 to 0.948)
OG0010.864(0.728 to 1.025)
OG0020.935(0.787 to 1.110)
0.800
(0.566 to 1.132)
OG0010.780(0.567 to 1.074)
OG0020.926(0.684 to 1.255)
0.106
(0.076 to 0.147)
OG0010.130(0.097 to 0.175)
OG0020.205(0.155 to 0.273)
0.138
(0.099 to 0.192)
OG0010.149(0.109 to 0.205)
OG0020.224(0.166 to 0.302)
0.194
(0.134 to 0.281)
OG0010.155(0.109 to 0.221)
OG0020.243(0.173 to 0.342)
0.230
(0.163 to 0.325)
OG0010.161(0.108 to 0.241)
OG0020.245(0.170 to 0.355)
0.074
(0.043 to 0.125)
OG0010.062(0.037 to 0.104)
OG0020.076(0.046 to 0.126)
0.099
(0.044 to 0.224)
OG0010.102(0.049 to 0.213)
OG0020.082(0.038 to 0.177)
NA
(NA to NA)
Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG001NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
OG002NA(NA to NA)Median, UL and LL not estimable by KM methodology due to insufficient number of events.
622
OG001644
OG002627
582
OG001601
OG002596
538
OG001576
OG002569
506
OG001518
OG002517
478
OG001528
OG002512
121
OG001145
OG002149
260
OG001323
OG002338
220
OG001264
OG002271
204
OG001223
OG002223
177
OG001213
OG002209
53
OG00159
OG00257
-0.702
± 0.809
OG001-0.657± 0.713
OG002-0.671± 0.706
-0.992
± 0.882
OG001-0.947± 0.825
OG002-0.977± 0.764
-1.241
± 1.012
OG001-1.214± 0.980
OG002-1.233± 0.949
-1.485
± 1.079
OG001-1.478± 1.014
OG002-1.544± 1.017
-1.889
± 1.288
OG001-1.696± 1.118
OG002-1.922± 1.290
-1.283
± 1.206
OG001-1.298± 1.133
OG002-1.355± 1.121
-0.072
± 0.855
OG001-0.082± 0.615
OG002-0.086± 0.632
-0.105
± 0.876
OG001-0.100± 0.529
OG002-0.109± 0.656
-0.162
± 1.025
OG001-0.148± 0.611
OG002-0.103± 1.460
-0.182
± 1.062
OG001-0.174± 0.675
OG002-0.148± 0.580
-0.248
± 1.256
OG001-0.239± 0.745
OG002-0.219± 0.672
-0.099
± NA
Insufficient number of assessments to calculate SD