Safety and Efficacy Study of RA101495 in Subjects With Ge... | NCT03315130 | Trialant
NCT03315130
Sponsor
Ra Pharmaceuticals
Status
Completed
Last Update Posted
Jul 27, 2022Actual
Enrollment
45Actual
Phase
Phase 2
Conditions
Generalized Myasthenia Gravis
Interventions
zilucoplan (RA101495)
Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT03315130
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RA101495-02.201
Secondary IDs
Not provided
Brief Title
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis
Acronym
Not provided
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Jul 2022
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 11, 2017Actual
Primary Completion Date
Dec 10, 2018Actual
Completion Date
Nov 19, 2020Actual
First Submitted Date
Oct 16, 2017
First Submission Date that Met QC Criteria
Oct 18, 2017
First Posted Date
Oct 19, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 31, 2022
Results First Submitted that Met QC Criteria
May 31, 2022
Results First Posted Date
Jun 27, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 25, 2020
Certification/Extension First Submitted that Passed QC Review
Aug 25, 2020
Certification/Extension First Posted Date
Sep 1, 2020Actual
Last Update Submitted Date
Jul 26, 2022
Last Update Posted Date
Jul 27, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ra PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Generalized Myasthenia Gravis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
45Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
0.1 mg/kg zilucoplan (RA101495)
Experimental
Drug: zilucoplan (RA101495)
0.3 mg/kg zilucoplan (RA101495)
Experimental
Drug: zilucoplan (RA101495)
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
zilucoplan (RA101495)
Drug
Daily subcutaneous (SC) injection
0.1 mg/kg zilucoplan (RA101495)
0.3 mg/kg zilucoplan (RA101495)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Main Portion: Change From Baseline to Week 12 in Quantitative Myasthenia Gravis (QMG) Score
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for myasthenia gravis (MG). The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
From Baseline to Week 12
Secondary Outcomes
Measure
Description
Time Frame
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale
The MG-ADL is a brief 8-item survey designed to evaluate MG symptom severity. The scale consists of 8 items each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the 8 individual scores with range of 0-24. Higher scores are associated with more severe symptoms of MG.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at Screening
Positive serology for acetylcholine receptor (AChR) autoantibodies
QMG score ≥ 12 at Screening and Randomization
No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
Exclusion Criteria:
Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period
History of meningococcal disease
Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization
Howard JF Jr, Nowak RJ, Wolfe GI, Freimer ML, Vu TH, Hinton JL, Benatar M, Duda PW, MacDougall JE, Farzaneh-Far R, Kaminski HJ; Zilucoplan MG Study Group; Barohn R, Dimachkie M, Pasnoor M, Farmakidis C, Liu T, Colgan S, Benatar MG, Bertorini T, Pillai R, Henegar R, Bromberg M, Gibson S, Janecki T, Freimer M, Elsheikh B, Matisak P, Genge A, Guidon A, David W, Habib AA, Mathew V, Mozaffar T, Hinton JL, Hewitt W, Barnett D, Sullivan P, Ho D, Howard JF Jr, Traub RE, Chopra M, Kaminski HJ, Aly R, Bayat E, Abu-Rub M, Khan S, Lange D, Holzberg S, Khatri B, Lindman E, Olapo T, Sershon LM, Lisak RP, Bernitsas E, Jia K, Malik R, Lewis-Collins TD, Nicolle M, Nowak RJ, Sharma A, Roy B, Nye J, Pulley M, Berger A, Shabbir Y, Sachdev A, Patterson K, Siddiqi Z, Sivak M, Bratton J, Small G, Kohli A, Fetter M, Vu T, Lam L, Harvey B, Wolfe GI, Silvestri N, Patrick K, Zakalik K, Duda PW, MacDougall J, Farzaneh-Far R, Pontius A, Hoarty M. Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial. JAMA Neurol. 2020 May 1;77(5):582-592. doi: 10.1001/jamaneurol.2019.5125.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The Participant flow refers to the Intent-to-treat Set for the main portion and Safety Set for the extension portion.
Recruitment Details
The study started to enroll participants in October 2017 and concluded in November 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RA101495 0.1 mg/kg
Participants received RA101495 0.1 milligram/kilogram (mg/kg) as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension portion, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion (EP).
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Quality of Life 15r (MG-QOL15r) Survey
The MG-QOL15r is a 15-item survey that was designed to assess quality of life in participants with MG. The survey consisted of 15 questions and the corresponding responses were each scored on a 0-2 point scale (0=Not much at all, 1=Somewhat, 2=Very Much). The total score is the sum of the 15 individual item scores with a range of 0-30. Higher scores indicate more severe impact of the disease on aspects of the participant's life.
From Baseline to Week 12
Main Portion: Change From Baseline to Week 12 in the MG Composite Scale Total Score
The MG Composite is a 10-item scale that has been used to measure the clinical status of participants with MG, in order to evaluate treatment response. It consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5). The total score is the sum of the 10 individual scores with a range of 0-50. Higher scores in the MG Composite indicate more severe impairment due to the disease.
From Baseline to Week 12
Main Portion: Percentage of Participants With >= 3-point Reduction in QMG Total Score at Week 12
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
Week 12
Main Portion: Percentage of Participants Who Required Rescue Therapy Over the 12-week Treatment Period
Percentage of participants who used at least 1 dose of rescue medication were reported.
Up to Week 12
Main Portion: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
From Baseline to Week 12
Main Portion: Change From Baseline in Sheep Red Blood Cell (sRBC) Lysis Assay at Week 12 (Pre-dose)
A BioTek ELx800 automated microplate reader is used to measure the optical density at 415 nanometer (nm) of human plasma samples to calculate the percent lysis of sheep erythrocytes that has occurred as a result of total complement activity. The measure of complement activity is determined by the degree of hemolysis of the erythrocytes.
Baseline and Week 12 (Pre-dose)
Main Portion: Change From Baseline in C5 Levels at Week 12 (Pre-dose)
Blood samples were collected from participants to assess Complement Component 5C levels.
Baseline and Week 12 (Pre-dose)
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758 and RA103488 are the metabolites of RA101495.
1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12
Main Portion: Maximum Plasma Concentration (Cmax) on Day 1
Cmax is defined as the maximum observed plasma concentration.
Pre-dose, 1, 3 and 6 hours postdose on Day 1
Main Portion: Time Corresponding to Cmax (Tmax) on Day 1
Tmax is defined as the time to observe maximum plasma concentration.
Pre-dose, 1, 3 and 6 hours postdose on Day 1
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758 and RA103488 are the metabolites of RA101495.
Pre-dose, 1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12
Carlsbad
California
92011
United States
UCLA Medical Center
Los Angeles
California
90095
United States
University of California Irvine Health ALS and Neuromuscular Center
Orange
California
92868
United States
Yale University
New Haven
Connecticut
06520
United States
George Washington University
Washington D.C.
District of Columbia
20052
United States
University of Florida
Jacksonville
Florida
32209
United States
University of South Florida
Tampa
Florida
33620
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
University of Maryland
Baltimore
Maryland
21201
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Lahey Hospital and Medical Center
Burlington
Massachusetts
01805
United States
Wayne State University
Detroit
Michigan
48202
United States
Michigan State University
East Lansing
Michigan
48864
United States
University of Buffalo
Buffalo
New York
14260
United States
Hospital for Special Surgery
New York
New York
10021
United States
Mount Sinai Hospital
New York
New York
10029
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Ohio State University
Columbus
Ohio
43210
United States
Allegheny Neurological Associates
Pittsburgh
Pennsylvania
15212
United States
Wesley Neurology Clinic
Cordova
Tennessee
38018
United States
University of Texas Southwestern
Dallas
Texas
75390
United States
University of Utah
Salt Lake City
Utah
84132
United States
University of Vermont
Burlington
Vermont
05405
United States
Center for Neurological Disorders
Milwaukee
Wisconsin
53215
United States
University of Alberta Hospital
Edmonton
Alberta
T6G 2B7
Canada
London Health Sciences Centre University Hospital
London
Ontario
N6A 5A5
Canada
Toronto General Hospital
Toronto
Ontario
M5G 2C4
Canada
Montreal Neurological Institute and Hospital
Montreal
Quebec
H3A 2B4
Canada
FG001
RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
FG002
Placebo
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
FG003
RA101495 0.1 mg/kg (Before Switch) to 0.3 mg/kg (After Switch)
Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG0030 subjects
COMPLETED
FG00015 subjects
FG00113 subjects
FG00215 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Subject withdrew consent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
EP:Before Switch to 0.3 mg/kg(Week13-48)
Type
Comment
Milestone Data
STARTED
FG00022 subjects(15 \[who received RA101495 0.1 mg/kg\] + 7 \[crossover from placebo\])
FG00121 subjects(14 \[who received RA101495 0.3 mg/kg + 7 \[crossover from placebo\] + 1 \[Subject who withdrew consent in Main Portion rejoined\])
FG0020 subjects
FG0030 subjects
COMPLETED
FG00021 subjects
FG00121 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Subject withdrew consent
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
EP:After Switch to 0.3 mg/kg(Week48-122)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00121 subjects
FG0020 subjects
FG00321 subjects
COMPLETED
FG0000 subjects
FG00117 subjects
FG0020 subjects
FG00320 subjects
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Intent-to-Treat (ITT) population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RA101495 0.1 mg/kg
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
BG001
RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for generalized myasthenia gravis (gMG). In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
BG002
Placebo
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants were randomized to receive either RA101495 0.1 mg/kg (up to 48 weeks) or RA101495 0.3 mg/kg (up to 122 weeks) in the extension portion, as a subcutaneous injection once daily.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00115
BG00215
BG00345
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
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.5± 15.6
BG00154.5± 14.9
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Main Portion: Change From Baseline to Week 12 in Quantitative Myasthenia Gravis (QMG) Score
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for myasthenia gravis (MG). The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
The modified ITT (mITT) population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Least Squares Mean
Standard Error
score on a scale
From Baseline to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG002
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-5.5± 1.2
OG001-6.0± 1.2
OG002-3.2± 1.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
=0.0941
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-2.3
Standard Error of the Mean
1.7
2-Sided
80
-4.5
-0.1
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Secondary
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale
The MG-ADL is a brief 8-item survey designed to evaluate MG symptom severity. The scale consists of 8 items each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the 8 individual scores with range of 0-24. Higher scores are associated with more severe symptoms of MG.
The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Least Squares Mean
Standard Error
score on a scale
From Baseline to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG002
Placebo (mITT)
Secondary
Main Portion: Change From Baseline to Week 12 in the Myasthenia Gravis - Quality of Life 15r (MG-QOL15r) Survey
The MG-QOL15r is a 15-item survey that was designed to assess quality of life in participants with MG. The survey consisted of 15 questions and the corresponding responses were each scored on a 0-2 point scale (0=Not much at all, 1=Somewhat, 2=Very Much). The total score is the sum of the 15 individual item scores with a range of 0-30. Higher scores indicate more severe impact of the disease on aspects of the participant's life.
The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Least Squares Mean
Standard Error
score on a scale
From Baseline to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG002
Secondary
Main Portion: Change From Baseline to Week 12 in the MG Composite Scale Total Score
The MG Composite is a 10-item scale that has been used to measure the clinical status of participants with MG, in order to evaluate treatment response. It consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5). The total score is the sum of the 10 individual scores with a range of 0-50. Higher scores in the MG Composite indicate more severe impairment due to the disease.
The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Least Squares Mean
Standard Error
score on a scale
From Baseline to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Secondary
Main Portion: Percentage of Participants With >= 3-point Reduction in QMG Total Score at Week 12
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG002
Placebo (mITT)
Secondary
Main Portion: Percentage of Participants Who Required Rescue Therapy Over the 12-week Treatment Period
Percentage of participants who used at least 1 dose of rescue medication were reported.
The mITT population included all participants in the ITT population who had received at least 1 dose of study drug.
Posted
Number
percentage of participants
Up to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (mITT)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG001
RA101495 0.3 mg/kg (mITT)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
OG002
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Secondary
Main Portion: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulted in death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.
The safety population included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
Posted
Count of Participants
Participants
From Baseline to Week 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (SS)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the safety set (SS) population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
OG001
RA101495 0.3 mg/kg (SS)
Secondary
Main Portion: Change From Baseline in Sheep Red Blood Cell (sRBC) Lysis Assay at Week 12 (Pre-dose)
A BioTek ELx800 automated microplate reader is used to measure the optical density at 415 nanometer (nm) of human plasma samples to calculate the percent lysis of sheep erythrocytes that has occurred as a result of total complement activity. The measure of complement activity is determined by the degree of hemolysis of the erythrocytes.
The pharmacodynamic (PD) population included all participants in mITT Population who had at least 1 evaluable PD assessment.
Posted
Least Squares Mean
Standard Error
percent lysis of sheep erythrocytes
Baseline and Week 12 (Pre-dose)
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PD)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
OG001
RA101495 0.3 mg/kg (PD)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
OG002
Placebo (PD)
Secondary
Main Portion: Change From Baseline in C5 Levels at Week 12 (Pre-dose)
Blood samples were collected from participants to assess Complement Component 5C levels.
The PD population included all participants in mITT Population who had at least 1 evaluable PD assessment.
Posted
Least Squares Mean
Standard Error
micrograms/milliliter (ug/mL)
Baseline and Week 12 (Pre-dose)
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PD)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
OG001
RA101495 0.3 mg/kg (PD)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
OG002
Placebo (PD)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
Secondary
Main Portion: Plasma Concentration of RA101495 and Its Major Metabolites
RA102758 and RA103488 are the metabolites of RA101495.
The pharmacokinetic (PK) population included all participants in mITT population who had at least 1 evaluable PK assessment. Here "Number Analyzed" signifies number of participants who were evaluable at specified time points. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Posted
Mean
Standard Deviation
nanograms/milliliter (ng/mL)
1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PK)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
OG001
RA101495 0.3 mg/kg (PK)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
Secondary
Main Portion: Maximum Plasma Concentration (Cmax) on Day 1
Cmax is defined as the maximum observed plasma concentration.
The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose, 1, 3 and 6 hours postdose on Day 1
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PK)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
OG001
RA101495 0.3 mg/kg (PK)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
Units
Counts
Secondary
Main Portion: Time Corresponding to Cmax (Tmax) on Day 1
Tmax is defined as the time to observe maximum plasma concentration.
The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Posted
Median
Full Range
hours
Pre-dose, 1, 3 and 6 hours postdose on Day 1
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PK)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
OG001
RA101495 0.3 mg/kg (PK)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
Units
Counts
Secondary
Main Portion: Metabolites (RA102758 and RA103488) to Parent Ratio
RA102758 and RA103488 are the metabolites of RA101495.
The PK Population included all participants in mITT population who had at least 1 evaluable PK assessment. Here "Number Analyzed" signifies number of participants who were evaluable at specified time points. 1 Participant (who was randomized to Placebo) mistakenly received Zilucoplan on Day 1 following a dispensing error (which was documented as a minor PD). Due to data confidentiality reasons, the results have not been reported for the placebo arm.
Posted
Mean
Standard Deviation
ratio
Pre-dose, 1, 3 and 6 hours postdose on Day 1; Pre-dose on Week 1, 2, 4, 8 and 12
ID
Title
Description
OG000
RA101495 0.1 mg/kg (PK)
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
OG001
RA101495 0.3 mg/kg (PK)
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the PK population which included all participants in mITT population who had at least 1 evaluable PK assessment.
Time Frame
From Baseline up to Week 122
Description
Treatment emergent adverse events (TEAEs) are defined as an AE that occurs after a treatment start date or an AE that increases in severity after treatment start date. In this study, AEs were planned to be reported for Main portion and Main + Extension portion only.
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
Main Portion: RA101495 0.1 mg/kg
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion.
0
15
0
15
15
15
EG001
Main Portion: RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion
0
14
5
14
12
14
EG002
Main Portion: Placebo
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion.
0
15
3
15
14
15
EG003
Main and Extension Portion: RA101495 0.1 mg/kg Before Switch to 0.3 mg/kg
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to 48 weeks (until protocol amendment v3.0) in the extension portion.
1
22
5
22
22
22
EG004
Main and Extension Portion: RA101495 0.1 mg/kg After Switch to 0.3 mg/kg
Participants received RA101495 0.1 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants who completed main portion and were eligible to enter in the extension period, continued receiving RA101495 0.1 mg/kg up to Week 48 (until protocol amendment v3.0). Following implementation of protocol amendment v3.0, and upon appropriate reconsent, all study participants ongoing in the extension portion who had previously received the RA101495 0.1mg/kg/day dose switched to receive the RA101495 0.3mg/kg/day until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
0
21
4
21
17
21
EG005
Main and Extension Portion: RA101495 0.3 mg/kg
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. At the end of the treatment period in the main portion, participants received the same dose of study drug in the extension portion until RA101495 is approved and available in the territory, or the sponsor terminates development of RA101495 for gMG. In countries where RA101495 is not approved or marketed, but in which sponsored clinical studies had been conducted, participants received RA101495 through a compassionate use pathway in the extension portion (up to 122 weeks).
2
21
11
21
21
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Worsening of Myasthenia Gravis
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0023 events3 affected15 at risk
EG0030 events0 affected22 at risk
EG004
Cellulitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Blood culture positive
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pancreas infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Liver abscess
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Intra-abdominal fluid collection
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Postoperative hypertension
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Rapidly progressive osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
COVID-19
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG0039 events6 affected22 at risk
EG0046 events5 affected21 at risk
EG0058 events8 affected21 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0006 events6 affected15 at risk
EG0013 events3 affected14 at risk
EG0025 events4 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0024 events4 affected15 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0003 events2 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Injection site bruising
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Injection site scab
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0004 events3 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Injection site nodule
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Fatigue
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events2 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Chills
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Amylase increased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0023 events2 affected15 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Cataract
Eye disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Worsening of Myasthenia Gravis
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0002 events2 affected15 at risk
EG0011 events1 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Viral infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Localised infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected15 at risk
EG003
Migraine with aura
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Tremor
Nervous system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected15 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Injection site pain
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Injection site discomfort
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected15 at risk
EG003
Swelling face
General disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Weight fluctuation
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected15 at risk
EG003
Hot flush
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected15 at risk
EG003
Cyanosis
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA v24.0
Non-systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events1 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v24.0
Non-systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-2.8
Standard Error of the Mean
1.7
2-Sided
80
-5.1
-0.6
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-3.3± 0.9
OG001-3.4± 0.9
OG002-1.1± 0.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
=0.0470
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-2.2
Standard Error of the Mean
1.3
2-Sided
80
-3.9
-0.5
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG001
OG002
ANCOVA
=0.0392
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-2.3
Standard Error of the Mean
1.3
2-Sided
80
-4.0
-0.6
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-7.4± 1.7
OG001-5.9± 1.7
OG002-2.1± 1.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
=0.0170
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-5.3
Standard Error of the Mean
2.4
2-Sided
80
-8.4
-2.1
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG001
OG002
ANCOVA
=0.0624
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-3.7
Standard Error of the Mean
2.4
2-Sided
80
-6.9
-0.6
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG002
Placebo (mITT)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-5.3± 1.5
OG001-7.4± 1.6
OG002-3.3± 1.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
=0.1866
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-2.0
Standard Error of the Mean
2.2
2-Sided
80
-4.9
0.9
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG001
OG002
ANCOVA
=0.0391
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-4.1
Standard Error of the Mean
2.2
2-Sided
80
-7.0
-1.1
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the mITT population which included all participants in the ITT population who had received at least 1 dose of study drug.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00171.4
OG00253.3
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG0006.7
OG0010
OG00220.0
Participants received RA101495 0.3 mg/kg as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the SS population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
OG002
Placebo (SS)
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed the SS population which included all participants who had received at least 1 dose of study drug (i.e., mITT Population), with participants to be analyzed based on the actual treatment received.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
AEs
Title
Measurements
OG00015
OG00112
OG00214
SAEs
Title
Measurements
OG0000
OG0015
OG0023
Participants received placebo matched to RA101495 as a subcutaneous injection once daily for 12 weeks in the main portion. Participants formed PD population which included all participants in mITT population who had at least 1 evaluable PD assessment.
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG000-81.822± 2.469
OG001-94.914± 2.908
OG0020.775± 2.571
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
<0.0001
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-82.597
Standard Error of the Mean
3.563
2-Sided
80
-87.249
-77.946
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG001
OG002
ANCOVA
<0.0001
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
-95.689
Standard Error of the Mean
3.910
2-Sided
80
-100.794
-90.585
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Units
Counts
Participants
OG00015
OG00114
OG00215
Title
Denominators
Categories
Title
Measurements
OG00057.349± 7.057
OG00154.302± 6.804
OG002-2.774± 6.237
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
<0.0001
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
60.123
Standard Error of the Mean
9.394
2-Sided
80
47.839
72.408
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
OG001
OG002
ANCOVA
<0.0001
1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.
LS Mean Difference
57.076
Standard Error of the Mean
9.269
2-Sided
80
44.955
69.197
LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.
Superiority
Units
Counts
Participants
OG00015
OG00114
Title
Denominators
Categories
RA101495- Day 1: 1 hour postdose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000652.136± 354.652
OG0012272.257± 1246.128
RA101495- Day 1: 3 hours postdose
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG0001691.267± 469.766
OG001
RA101495- Day 1: 6 hours postdose
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG0001925.357± 330.335
OG001
RA101495- Week 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG0004571.214± 719.566
OG001
RA101495- Week 2: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0004914.200± 743.215
OG001
RA101495- Week 4: Pre-dose
ParticipantsOG00014
ParticipantsOG00112
Title
Measurements
OG0005100.286± 859.767
OG001
RA101495- Week 8: Pre-dose
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG0005222.067± 688.427
OG001
RA101495- Week 12: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0005281.333± 1122.372
OG001
RA102758- Day 1: 1 hour postdose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above lower limit of quantification (LLOQ).
OG001
RA102758- Day 1: 3 hours postdose
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA102758- Day 1: 6 hours postdose
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA102758- Week 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000252.693± 78.909
OG001
RA102758- Week 2: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG000408.847± 94.773
OG001
RA102758- Week 4: Pre-dose
ParticipantsOG00014
ParticipantsOG00112
Title
Measurements
OG000462.486± 180.098
OG001
RA102758- Week 8: Pre-dose
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG000474.073± 157.549
OG001
RA102758- Week 12: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG000465.665± 195.227
OG001
RA103488- Day 1: 1 hour postdose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA103488- Day 1: 3 hours postdose
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA103488- Day 1: 6 hours postdose
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA103488- Week 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000356.186± 162.209
OG001
RA103488- Week 2: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG000501.847± 218.467
OG001
RA103488- Week 4: Pre-dose
ParticipantsOG00014
ParticipantsOG00112
Title
Measurements
OG000536.266± 275.013
OG001
RA103488- Week 8: Pre-dose
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG000615.740± 229.359
OG001
RA103488- Week 12: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG000621.813± 241.354
OG001
Participants
OG00015
OG00114
Title
Denominators
Categories
Title
Measurements
OG0001945.467± 407.273
OG0014858.643± 1004.457
Participants
OG00015
OG00114
Title
Denominators
Categories
Title
Measurements
OG0004.550(2.95 to 5.50)
OG0014.700(2.62 to 5.92)
Units
Counts
Participants
OG00015
OG00114
Title
Denominators
Categories
RA102758/RA101495- Day 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
RA102758/RA101495- Day 1: 1 hour postdose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG0000.000± 0.000
OG001
RA102758/RA101495- Day 1: 3 hours postdose
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG0000.000± 0.000
OG001
RA102758/RA101495- Day 1: 6 hours postdose
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG0000.000± 0.000
OG001
RA102758/RA101495- Week 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG0000.121± 0.033
OG001
RA102758/RA101495- Week 2: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0000.182± 0.038
OG001
RA102758/RA101495- Week 4: Pre-dose
ParticipantsOG00013
ParticipantsOG00112
Title
Measurements
OG0000.197± 0.072
OG001
RA102758/RA101495- Week 8: Pre-dose
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG0000.195± 0.057
OG001
RA102758/RA101495- Week 12: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0000.184± 0.065
OG001
RA103488/RA101495- Day 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG000NA± NAMean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
OG001
RA103488/RA101495- Day 1: 1 hour postdose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG0000.000± 0.000
OG001
RA103488/RA101495- Day 1: 3 hours postdose
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG0000.000± 0.000
OG001
RA103488/RA101495- Day 1: 6 hours postdose
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG0000.000± 0.000
OG001
RA103488/RA101495- Week 1: Pre-dose
ParticipantsOG00014
ParticipantsOG00114
Title
Measurements
OG0000.079± 0.037
OG001
RA103488/RA101495- Week 2: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0000.104± 0.044
OG001
RA103488/RA101495- Week 4: Pre-dose
ParticipantsOG00013
ParticipantsOG00112
Title
Measurements
OG0000.106± 0.046
OG001
RA103488/RA101495- Week 8: Pre-dose
ParticipantsOG00015
ParticipantsOG00112
Title
Measurements
OG0000.118± 0.044
OG001
RA103488/RA101495- Week 12: Pre-dose
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0000.116± 0.035
OG001
0 events
0 affected
21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0042 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
3 events
3 affected
22 at risk
EG0043 events2 affected21 at risk
EG0055 events4 affected21 at risk
3 events
3 affected
22 at risk
EG0042 events2 affected21 at risk
EG0052 events1 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0054 events4 affected21 at risk
0 events
0 affected
22 at risk
EG0041 events1 affected21 at risk
EG0054 events4 affected21 at risk
2 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
4 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0056 events5 affected21 at risk
1 events
1 affected
22 at risk
EG0042 events2 affected21 at risk
EG0053 events1 affected21 at risk
2 events
2 affected
22 at risk
EG0041 events1 affected21 at risk
EG0055 events3 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
13 events
10 affected
22 at risk
EG0044 events3 affected21 at risk
EG00510 events4 affected21 at risk
4 events
4 affected
22 at risk
EG0043 events3 affected21 at risk
EG0053 events3 affected21 at risk
3 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
3 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
7 events
4 affected
22 at risk
EG0041 events1 affected21 at risk
EG0058 events5 affected21 at risk
3 events
2 affected
22 at risk
EG0042 events2 affected21 at risk
EG0054 events3 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0056 events5 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
13 events
6 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
4 events
3 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0042 events2 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0053 events3 affected21 at risk
2 events
2 affected
22 at risk
EG0041 events1 affected21 at risk
EG0053 events2 affected21 at risk
3 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
3 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0052 events2 affected21 at risk
3 events
3 affected
22 at risk
EG0041 events1 affected21 at risk
EG0057 events5 affected21 at risk
2 events
1 affected
22 at risk
EG0042 events2 affected21 at risk
EG0052 events1 affected21 at risk
2 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
4 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
2 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0058 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
3 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
2 events
2 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
2 events
1 affected
22 at risk
EG0042 events1 affected21 at risk
EG0052 events2 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
6 events
4 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events3 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
3 events
3 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0054 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events1 affected21 at risk
3 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0042 events2 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
2 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
2 events
1 affected
22 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0053 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
1 events
1 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
2 events
2 affected
22 at risk
EG0040 events0 affected21 at risk
EG0052 events2 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
0 events
0 affected
22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
4176.000
± 1211.166
4636.000
± 809.804
9223.786
± 2365.168
10222.846
± 1662.869
10265.917
± 1604.004
10075.000
± 1872.400
10284.846
± 1771.586
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
849.743
± 273.388
1473.431
± 440.496
1567.692
± 557.745
1432.808
± 530.377
1459.062
± 451.013
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.
85.832
± 257.664
838.907
± 255.419
1135.731
± 270.004
1191.783
± 251.853
1234.708
± 201.055
1307.492
± 331.553
0.000
± 0.000
0.000
± 0.000
0.013
± 0.044
0.202
± 0.038
0.307
± 0.057
0.323
± 0.072
0.301
± 0.070
0.303
± 0.061
NA
± NA
Mean and Standard Deviation are only calculated if at least 2/3 of the individual data points are above LLOQ.