Study of an Investigational Drug, RO7239361 (BMS-986089),... | NCT02515669 | Trialant
NCT02515669
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Nov 4, 2020Actual
Enrollment
43Actual
Phase
Phase 1Phase 2
Conditions
Muscular Dystrophy (DMD)
Interventions
RO7239361
Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02515669
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CN001-006
Secondary IDs
ID
Type
Description
Link
WN40226
Other Identifier
Hoffman-La Roche
Brief Title
Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD
Official Title
A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Oct 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
A pre-planned futility analysis indicated lack of efficacy in study NCT03039686 and led to discontinuation of both ongoing studies in DMD.
Expanded Access Info
No
Start Date
Dec 2, 2015Actual
Primary Completion Date
Feb 8, 2018Actual
Completion Date
Apr 15, 2020Actual
First Submitted Date
Jul 29, 2015
First Submission Date that Met QC Criteria
Aug 3, 2015
First Posted Date
Aug 5, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 7, 2019
Results First Submitted that Met QC Criteria
Apr 17, 2019
Results First Posted Date
May 8, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 13, 2020
Last Update Posted Date
Nov 4, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and tolerability of RO7239361 in boys with Duchenne Muscular Dystrophy with any genetic mutation.
Detailed Description
Not provided
Conditions Module
Conditions
Muscular Dystrophy (DMD)
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
RO7239361
Active Comparator
RO7239361 subcutaneous injections on specified days
Drug: RO7239361
Placebo
Placebo Comparator
Placebo subcutaneous injections on specified days
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7239361
Drug
Colorless to slightly yellow, clear to opalescent solution, essentially free of particulate matter packaged in a 1 cc glass syringe equipped with a safety syringe device.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Summary for the 24 Week Double-Blind Phase
Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline to Week 24
Safety Summary up to Week 72
Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 72.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline to Week 72
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361. No participants received the Panel 2 20mg dose.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with DMD
Able to walk without assistance
Able to walk up 4 stairs in 8 seconds or less
Weigh at least 15 kg
Taking corticosteroids for DMD
Exclusion Criteria:
Ejection fraction < 55% on echocardiogram, based on central read
Any behavior or mental issue that will affect the ability to complete the required study procedures
Previously or currently taking medications like androgens or human growth hormone
Use of a ventilator during the day
Unable to have blood samples collected or receive an injection under the skin
Treatment with exon skipping therapies 6 months prior to study start
Treatment with ataluren or any investigational drug currently or within 5 half-lives prior to study start
Muntoni F, Byrne BJ, McMillan HJ, Ryan MM, Wong BL, Dukart J, Bansal A, Cosson V, Dreghici R, Guridi M, Rabbia M, Staunton H, Tirucherai GS, Yen K, Yuan X, Wagner KR; Taldefgrobep Alfa Study Group. The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy. Neurol Ther. 2024 Feb;13(1):183-219. doi: 10.1007/s40120-023-00570-w. Epub 2024 Jan 8.
Starting at Week 5, participants whose weight exceeded or dropped below the dosing weight tier to which they were assigned (by >1kg) were assigned to the new corresponding body weight-based dose within the participants assigned panel.
Recruitment Details
Doses for this study are based upon achieving a moderate to high degree of suppression in serum free myostatin at steady-state trough across 3 dose levels. A body weight-tiered, fixed-dose strategy targeting moderate (>50%), high (>85%) and near complete (>95%) suppression of serum free myostatin was used to select the three doses for the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo subcutaneous injections on specified days
FG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
Colorless to slightly yellow, clear to opalescent solution, essentially free of particulate matter packaged in a 1 cc glass syringe equipped with a safety syringe device.
Placebo
Day 1: predose, 3, 6, 72 and 96 hours (h) postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW.
Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 6. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW
Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 8. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
RO7239361 Trough Concentrations
Trough concentrations of RO7239361 at different dose levels.
Panel 1 = 4mg, Panel 2 = 12.5mg and 20mg, Panel 3 = 35mg, Expansion Panels = 35mg and 50mg.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 8 through Week 24, baseline and on-study information represented in table.
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Double-blind phase data for placebo participants is not included. Placebo participants in each arm moved on to RO7239361 upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 8 through Week 72, baseline and on-study information represented in table.
Serum Concentration of Free Myostatin in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 24
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 24
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 24
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
Ratio of contractile vs non-contractile content is contractile content / non-contractile content. Fold change from baseline of the ratio is defined as the ratio of fold change from baseline of contractile content vs fold change from baseline of non-contractile content.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 24
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 24
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Day 8 through Week 228, baseline and on-study information represented in table.
Serum Concentration of Free Myostatin, Whole Study
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 252
Percent Inhibition of Free Myostatin, Whole Study
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 252
Serum Concentration of Drug-Myostatin Complex, Whole Study
Participants in the Placebo arm received placebo during the double-blind (DB) period (up to Week 24) and received RO7239361 during the open label (OL) phase. PFS in table row title indicates when study drug was changed from vial to prefilled syringe (PFS).
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Baseline through Week 252
Palo Alto
California
94305
United States
University of Florida
Gainesville
Florida
32607
United States
Nemours Children's Hospital
Orlando
Florida
32827
United States
Children's Healthcare of Atlanta
Atlanta
Georgia
30324
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
Kennedy Krieger Institute
Baltimore
Maryland
21205
United States
Saint Louis Children's Hospital
St Louis
Missouri
63110
United States
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
45229
United States
Alberta Children's Hospital
Calgary
Alberta
T3B 6A8
Canada
Children'S Hospital of Eastern Ontario
Ottawa
Ontario
K1H 8L1
Canada
FG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
FG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
FG00011 subjects
FG0017 subjects
FG0026 subjects
FG00319 subjects
COMPLETED
FG00011 subjects
FG0017 subjects
FG0026 subjects
FG00319 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
228 Week Open-Label Phase
Type
Comment
Milestone Data
STARTED
Participants assigned to placebo in the double blind phase switched to RO for the open-label phase
FG0000 subjectsDouble-blind (DB) placebo participants switched to RO7239361 (RO) for the open label phase.
FG0019 subjects2 DB placebo participants switched to the Panel 1 RO cohort for the open-label phase.
FG0028 subjects2 DB placebo participants switched to the Panel 2 RO cohort for the open-label phase.
FG00326 subjects7 DB placebo participants switched to the Panel 3/Expansion RO cohort for the open-label phase.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0019 subjects
FG0028 subjects
FG00326 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Doses tested in this study were based upon achieving and maintaining moderate (> 50% suppression), high (> 85%), and near complete (> 95%) suppression of serum free myostatin levels for Panels 1, 2, and 3 and Expansion Panel, respectively. Panel 3 was expanded after at least 2 weeks of dosing had been complete by at least 6 participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo subcutaneous injections on specified days
BG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
BG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
BG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG0017
BG0026
BG00319
BG00443
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0008.8± 1.33
BG0018.0± 2.24
BG0028.0± 1.79
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Safety Summary for the 24 Week Double-Blind Phase
Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Number
percentage of participants
Baseline to Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG003
Panel 3 and Expansion RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG003
Title
Denominators
Categories
Death
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Safety Summary up to Week 72
Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 72.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Number
percentage of participants
Baseline to Week 72
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Secondary
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361. No participants received the Panel 2 20mg dose.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/ml
Day 1: predose, 3, 6, 72 and 96 hours (h) postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG000
Secondary
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW.
Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 6. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Median
Full Range
hour
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Median
Full Range
hour
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG000
Secondary
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.
PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.
Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW
Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 8. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•day/mL
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 50 mg QW Dose.
PK parameter estimates at steady state following approximately 12 weeks QW administration.
Panel 3 = 50 mg QW
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•day/mL
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG000
Secondary
RO7239361 Trough Concentrations
Trough concentrations of RO7239361 at different dose levels.
Panel 1 = 4mg, Panel 2 = 12.5mg and 20mg, Panel 3 = 35mg, Expansion Panels = 35mg and 50mg.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Pharmacokinetic population. Panel 2, 20mg dose: the number of participants analyzed is 0 in those instances that the treatment was not administered at that visit.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1: predose, 3, 6, 72 and 96 h postdose; Days 8, 15 and 22: predose; Day 29: predose and 96 h postdose; Weeks 12 and 24: predose
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361 12.5mg
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Number
percentage of participants
Day 8 through Week 24, baseline and on-study information represented in table.
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment up to Week 72
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Double-blind phase data for placebo participants is not included. Placebo participants in each arm moved on to RO7239361 upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
Posted
Number
percentage of participants
Day 8 through Week 72, baseline and on-study information represented in table.
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Serum Concentration of Free Myostatin in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Posted
Mean
Standard Deviation
pg/mL
Baseline through Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Percent Inhibition of Free Myostatin in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Posted
Mean
Standard Deviation
percentage inhibition
Baseline through Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Serum Concentration of Drug-Myostatin Complex in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint.
Posted
Mean
Standard Deviation
ng/mL
Baseline through Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh in the Double-Blind Phase
Ratio of contractile vs non-contractile content is contractile content / non-contractile content. Fold change from baseline of the ratio is defined as the ratio of fold change from baseline of contractile content vs fold change from baseline of non-contractile content.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.
Posted
Mean
Standard Error
Fold Change
Baseline through Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
Secondary
Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax) in the Double-Blind Phase
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.
Posted
Mean
Standard Error
Percentage Change
Baseline through Week 24
ID
Title
Description
OG000
Placebo
Placebo subcutaneous injections on specified days
OG001
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Percentage of Participants With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study
A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The safety population included all participants who received at least one dose of study drug. The Whole Study set reported here includes data from RO7239361-treated participants only.
Posted
Number
percentage of participants
Day 8 through Week 228, baseline and on-study information represented in table.
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
Secondary
Serum Concentration of Free Myostatin, Whole Study
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. The Whole Study set reported here includes data from RO7239361-treated participants only.
Posted
Mean
Standard Deviation
pg/mL
Baseline through Week 252
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Percent Inhibition of Free Myostatin, Whole Study
Double-blind phase data for placebo participants are not included in this Whole Study outcome measure, but are reported in the outcome measure specific to the double-blind period. At the end of the double-blind period participants in the placebo arm switched to one of the RO7239361 arms upon entering the open label phase.
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. The Whole Study set reported here includes data from RO7239361-treated participants only.
Posted
Mean
Standard Deviation
percentage inhibition
Baseline through Week 252
ID
Title
Description
OG000
Panel 1 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
Secondary
Serum Concentration of Drug-Myostatin Complex, Whole Study
Participants in the Placebo arm received placebo during the double-blind (DB) period (up to Week 24) and received RO7239361 during the open label (OL) phase. PFS in table row title indicates when study drug was changed from vial to prefilled syringe (PFS).
Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.
The pharmacodynamics (PD) data set included all available data from subjects for whom PD measurements were available at baseline and at least one other timepoint. Data are analyzed according to the arms in which participants started the study.
Posted
Mean
Standard Deviation
ng/mL
Baseline through Week 252
ID
Title
Description
OG000
Placebo, Then RO7239361
Placebo subcutaneous injections on specified days. At the end of the DB period these participants switched to treatment to treatment with RO7239361 at dose levels of either Panel 1, Panel 2 or Panel 3.
OG001
Panel 1 RO7239361 Whole Study
RO7239361 subcutaneous injections on specified days. The Panel 1 dose targets achievement of > 50% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. The Panel 1 body weight tier dose is >15kg at a dose of 4 mg (milligram) /0.8 mL (millilitre).
Time Frame
Baseline up to Week 252
Description
Upon completion of the double-blind phase, participants who were receiving placebo switched to the equivalent RO7239361 panel dose for the open label phase. All adverse event data is represented according to the phase (double-blind or open-label) during which the participant experienced the event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Double-Blind
Placebo subcutaneous injections on specified days during the double-blind period.
0
11
1
11
9
11
EG001
Panel 1 RO7239361 Double-Blind
RO7239361 subcutaneous injections on specified days during the double-blind period.
0
7
0
7
5
7
EG002
Panel 2 RO7239361 Double-Blind
RO7239361 subcutaneous injections on specified days during the double-blind period.
0
6
0
6
6
6
EG003
Panel 3 and Expansion Panel RO7239361 Double-Blind
RO7239361 subcutaneous injections on specified days during the double-blind period.
0
19
1
19
17
19
EG004
Panel 1 RO7239361 Open-Label
RO7239361 subcutaneous injections on specified days during the open-label period.
0
9
1
9
9
9
EG005
Panel 2 RO7239361 Open-Label
RO7239361 subcutaneous injections on specified days during the open label period.
0
8
2
8
6
8
EG006
Panel 3 and Expansion Panel RO7239361 Open-Label
RO7239361 subcutaneous injections on specified days during the open-label period.
0
26
1
26
24
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
APPENDICITIS PERFORATED
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
INFLUENZA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SKULL FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
RHABDOMYOLYSIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CONVERSION DISORDER
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CARDIOMYOPATHY
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
LEFT VENTRICULAR DYSFUNCTION
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MYOCARDIAL FIBROSIS
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DERMOID CYST
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
TYMPANIC MEMBRANE HYPERAEMIA
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
TYMPANIC MEMBRANE PERFORATION
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
ADRENAL INSUFFICIENCY
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CUSHINGOID
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DELAYED PUBERTY
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CATARACT
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DRY EYE
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
BREATH ODOUR
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events2 affected11 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
GASTRIC ULCER
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
HAEMATOCHEZIA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LIP SWELLING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
MALPOSITIONED TEETH
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MUCOUS STOOLS
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CHILLS
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
FATIGUE
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE BRUISING
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
INJECTION SITE DISCOMFORT
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE HAEMORRHAGE
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE IRRITATION
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0015 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE OEDEMA
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE PAIN
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE PRURITUS
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE RASH
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0011 events1 affected7 at risk
EG0029 events1 affected6 at risk
EG003
INJECTION SITE REACTION
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INJECTION SITE SWELLING
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PYREXIA
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
SEASONAL ALLERGY
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ABSCESS ORAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
BODY TINEA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LABYRINTHITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NAIL INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
ONYCHOMYCOSIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA MYCOPLASMAL
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SCARLET FEVER
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
SKIN CANDIDA
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
STAPHYLOCOCCAL SKIN INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
TOOTH ABSCESS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected11 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
VIRAL RHINITIS
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
CORNEAL ABRASION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EYE CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EYELID CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
FIBULA FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
FOOT FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
POST-TRAUMATIC PAIN
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SKIN ABRASION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SOFT TISSUE INJURY
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SUNBURN
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
TIBIA FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
UPPER LIMB FRACTURE
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LYMPH NODE PALPABLE
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
COCCYDYNIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
COSTOCHONDRITIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INTERVERTEBRAL DISC COMPRESSION
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
JOINT CONTRACTURE
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
OSTEOPOROSIS
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected7 at risk
EG0022 events2 affected6 at risk
EG003
PAIN IN JAW
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SYNOVIAL CYST
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected6 at risk
EG003
MOTOR DYSFUNCTION
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ANGER
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
BRUXISM
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ENURESIS
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
POLYURIA
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
TESTICULAR TORSION
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LOWER RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
NASAL DISCHARGE DISCOLOURATION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
SLEEP APNOEA SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
COLD SWEAT
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
EPHELIDES
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
INGROWING NAIL
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
LIVEDO RETICULARIS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0024 events3 affected6 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Subject Request to Discontinue Treatment
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
Administrative Reason by Sponsor
FG0000 subjects
FG0017 subjects
FG0022 subjects
FG00317 subjects
Missing
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
8.1
± 1.81
BG0048.2± 1.74
0
BG0030
BG0040
Male
BG00011
BG0017
BG0026
BG00319
BG00443
1
BG0032
BG0044
Not Hispanic or Latino
BG0009
BG0017
BG0025
BG00313
BG00434
Unknown or Not Reported
BG0001
BG0010
BG0020
BG0034
BG0045
0
BG0030
BG0041
Asian
BG0002
BG0010
BG0022
BG0035
BG0049
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
Black or African American
BG0000
BG0010
BG0021
BG0030
BG0041
White
BG0009
BG0016
BG0023
BG00313
BG00431
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG0041
19
0
Adverse Events (AEs)
Title
Measurements
OG00081.8
OG00171.4
OG002100.0
OG00394.7
AEs leading to study withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Serious Adverse Events (SAE)
Title
Measurements
OG0009.1
OG0010
OG0020
OG0035.3
Very Severe AEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Severe AEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Related AEs
Title
Measurements
OG00027.3
OG00114.3
OG00250.0
OG00336.8
Units
Counts
Participants
OG0009
OG0018
OG00226
Title
Denominators
Categories
Death
Title
Measurements
OG0000
OG0010
OG0020
Adverse Events (AEs)
Title
Measurements
OG000100.0
OG001100.0
OG00296.2
AEs leading to study withdrawal
Title
Measurements
OG0000
OG0010
OG0020
Serious Adverse Events (SAE)
Title
Measurements
OG0000
OG00125.0
OG0027.7
Very Severe AEs
Title
Measurements
OG0000
OG0010
OG0020
Severe AEs
Title
Measurements
OG0000
OG00125.0
OG0023.8
Related AEs
Title
Measurements
OG00077.8
OG00162.5
OG00250.0
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0007
OG0016
OG00219
Title
Denominators
Categories
Title
Measurements
OG0003217± 15.8
OG0018490± 21.5
OG00224242± 26.3
19
Title
Denominators
Categories
Title
Measurements
OG00023297± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose.
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0007
OG0016
OG00218
Title
Denominators
Categories
Title
Measurements
OG00028(12 to 48)
OG00124(11 to 47)
OG00230(11 to 65)
1
Title
Denominators
Categories
Title
Measurements
OG00044(NA to NA)Geometric Coefficient of Variation not evaluable as only one participant was included at this dose.
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0007
OG0016
OG00218
Title
Denominators
Categories
Title
Measurements
OG00018676± 23
OG00151461± 18
OG002150609± 24
1
Title
Denominators
Categories
Title
Measurements
OG000151000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose.
OG002
Panel 2 RO7239361 20mg
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL.
The dose was not administered at Days 1, 15, 22, 29 and 84.
OG003
Panel 3 RO7239361 35mg
RO7239361 subcutaneous injections on specified days. RO7239361 subcutaneous injections on specified days, The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG004
Expansion Panel RO7239361 35mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
OG005
Expansion Panel RO7239361 50mg
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0009
OG0017
OG0021
OG0037
OG00416
OG0051
Title
Denominators
Categories
Day 1
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG00412
ParticipantsOG0051
Title
Measurements
OG000825.343± 23
OG0012115.951± 20
OG0036559.364± 26
OG004
Day 15
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
Day 22
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0035
Day 29
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
Day 84
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0037
Day 168
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0021
ParticipantsOG0037
OG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG00319
Title
Denominators
Categories
Baseline (BL): ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
OG0030
BL: ADA Negative
Title
Measurements
OG0000
OG00171.4
OG002100.0
OG003
BL: Missing
Title
Measurements
OG000100.0
OG00128.6
OG0020
OG003
On-treatment: ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
On-treatment: Persistent Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
On-treatment: Only last sample Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
On-treatment: Other Positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
On-treatment: ADA Negative
Title
Measurements
OG0000
OG001100.0
OG002100.0
OG003
On-treatment: ADA Negative, BL Positive, No Boost
Title
Measurements
OG0000
OG0010
OG0020
OG003
On-treatment: Missing
Title
Measurements
OG000100.0
OG0010
OG0020
OG003
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0009
OG0018
OG00226
Title
Denominators
Categories
Baseline (BL): ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
BL: ADA Negative
Title
Measurements
OG00077.8
OG00187.5
OG00288.5
BL: Missing
Title
Measurements
OG00022.2
OG00112.5
OG00211.5
On-treatment: ADA Positive
Title
Measurements
OG0000
OG0010
OG0023.8
On-treatment: Persistent Positive
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: Only last sample Positive
Title
Measurements
OG0000
OG0010
OG0023.8
On-treatment: Other Positive
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: ADA Negative
Title
Measurements
OG000100.0
OG001100.0
OG00296.2
On-treatment: ADA Negative, BL Positive, No Boost
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG00319
Title
Denominators
Categories
Baseline
ParticipantsOG00011
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00316
Title
Measurements
OG0001405.1± 809.57
OG001815.3± 155.14
OG0021391.3± 1084.97
OG003
Day 4
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG00318
Day 5
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
Day 8
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Day 15
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00319
Day 22
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00317
Day 29
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00317
Day 33
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
Week 12
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00318
Week 24
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
OG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG00319
Title
Denominators
Categories
Day 4
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG00318
Title
Measurements
OG0000.595± 23.6952
OG00149.689± 11.7394
OG00273.533± 9.8637
OG003
Day 5
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
Day 8
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Day 15
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00319
Day 22
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00317
Day 29
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00317
Day 33
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
Week 12
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG00318
Week 24
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG00318
OG003
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG00319
Title
Denominators
Categories
Day 4
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0037
Title
Measurements
OG0001.178± 1.8833
OG0015.070± 0.9456
OG00212.606± 5.7623
OG003
Day 5
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0036
Day 8
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0037
Day 15
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
Day 22
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Day 29
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
Day 33
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG0037
Week 12
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00314
Week 24
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0037
OG002
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG003
Panel 3 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
OG004
Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG0036
OG00413
Title
Denominators
Categories
W12: ADDUCTOR LONGUS
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0034
ParticipantsOG00411
Title
Measurements
OG0001.04± 0.291
OG0010.95± 0.088
OG0021.16± 0.330
OG003
W12: ADDUCTOR MAGNUS
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0035
W12: BICEPS FEMORIS LONG
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0034
W12: BICEPS FEMORIS SHORT
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
W12: GRACILIS
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0034
W12:RECTUS FEMORIS
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0034
W12: SARTORIUS
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0034
W12: SEMIMEMBRANOSUS
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0036
W12: SEMITENDINOSUS
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0034
W12: VASTUS INTERMEDIUS
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
W12: VASTUS LATERALIS
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0035
W12: VASTUS MEDIALIS
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0034
W24: ADDUCTOR LONGUS
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0035
W24: ADDUCTOR MAGNUS
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0035
W24: BICEPS FEMORIS LONG
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0034
W24: BICEPS FEMORIS SHORT
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0035
W24: GRACILIS
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0034
W24:RECTUS FEMORIS
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0034
W24: SARTORIUS
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
W24: SEMIMEMBRANOSUS
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0034
W24: SEMITENDINOSUS
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0036
W24: VASTUS INTERMEDIUS
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0034
W24: VASTUS LATERALIS
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0025
ParticipantsOG0034
W24: VASTUS MEDIALIS
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
OG003
Panel 3RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
OG004
Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG0036
OG00413
Title
Denominators
Categories
W12: ADDUCTOR LONGUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG00412
Title
Measurements
OG0007.29± 16.559
OG0018.31± 11.767
OG0025.85± 11.074
OG003
W12: ADDUCTOR MAGNUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: BICEPS FEMORIS LONG
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: BICEPS FEMORIS SHORT
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: GRACILIS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12:RECTUS FEMORIS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: SARTORIUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: SEMIMEMBRANOSUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: SEMITENDINOSUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: VASTUS INTERMEDIUS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: VASTUS LATERALIS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W12: VASTUS MEDIALIS
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
W24: ADDUCTOR LONGUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: ADDUCTOR MAGNUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: BICEPS FEMORIS LONG
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: BICEPS FEMORIS SHORT
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: GRACILIS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24:RECTUS FEMORIS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: SARTORIUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: SEMIMEMBRANOSUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: SEMITENDINOSUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: VASTUS INTERMEDIUS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: VASTUS LATERALIS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
W24: VASTUS MEDIALIS
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0036
OG001
Panel 2 RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0009
OG0018
OG00226
Title
Denominators
Categories
Baseline (BL): ADA Positive
Title
Measurements
OG0000
OG0010
OG0020
BL: ADA Negative
Title
Measurements
OG000100.0
OG00187.5
OG00292.3
BL: Missing
Title
Measurements
OG0000
OG00112.5
OG0027.7
On-treatment: ADA Positive
Title
Measurements
OG0000
OG0010
OG0023.8
On-treatment: Persistent Positive
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: Only last sample Positive
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: Other Positive
Title
Measurements
OG0000
OG0010
OG0023.8
On-treatment: ADA Negative
Title
Measurements
OG000100.0
OG001100.0
OG00296.2
On-treatment: ADA Negative, BL Positive, No Boost
Title
Measurements
OG0000
OG0010
OG0020
On-treatment: Missing
Title
Measurements
OG0000
OG0010
OG0020
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0009
OG0018
OG00225
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00223
Title
Measurements
OG000986.8± 363.69
OG0011358.4± 964.47
OG0021159.3± 601.29
Day 4
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG00218
Title
Measurements
OG000
Day 5
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00218
Title
Measurements
OG000
Day 8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00219
Title
Measurements
OG000
Day 15
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00219
Title
Measurements
OG000
Day 22
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00217
Title
Measurements
OG000
Day 29
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00217
Title
Measurements
OG000
Day 33
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00218
Title
Measurements
OG000
Week 12
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG00225
Title
Measurements
OG000
Week 24
ParticipantsOG0009
ParticipantsOG0018
ParticipantsOG00224
Title
Measurements
OG000
Week 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00217
Title
Measurements
OG000
Week 36
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG00216
Title
Measurements
OG000
Week 60
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
Title
Measurements
OG000
Week 72
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
Title
Measurements
OG000
Week 84
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG00215
Title
Measurements
OG000
Week 108
ParticipantsOG0009
ParticipantsOG0015
ParticipantsOG00216
Title
Measurements
OG000
Week 132
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00221
Title
Measurements
OG000
Week 144
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 156
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0028
Title
Measurements
OG000
Week 180
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Week 252
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
OG002
Panel 3 and Expansion Panel RO7239361
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG0008
OG0018
OG00222
Title
Denominators
Categories
Day 4
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG00215
Title
Measurements
OG00049.689± 11.7394
OG00173.533± 9.8637
OG00295.334± 2.4477
Day 5
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00216
Title
Measurements
OG000
Day 8
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00216
Title
Measurements
OG000
Day 15
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00216
Title
Measurements
OG000
Day 22
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
Title
Measurements
OG000
Day 29
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
Title
Measurements
OG000
Day 33
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00222
Title
Measurements
OG000
Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00221
Title
Measurements
OG000
Week 25
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00215
Title
Measurements
OG000
Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00214
Title
Measurements
OG000
Week 60
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0027
Title
Measurements
OG000
Week 72
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0023
Title
Measurements
OG000
Week 84
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG00213
Title
Measurements
OG000
Week 108
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG00214
Title
Measurements
OG000
Week 132
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00218
Title
Measurements
OG000
Week 144
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
Week 156
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0026
Title
Measurements
OG000
Week 180
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG000
Week 252
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG001
OG002
Panel 2 RO7239361 Whole Study
RO7239361 subcutaneous injections on specified days. The Panel 2 dose targets achievement of > 85% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 2 body weight tier doses are =>15kg to =< 45kg at a dose of 12.5 mg /0.25 mL and =>45kg at a dose of 20 mg /0.4 mL
OG003
Panel 3 and Expansion Panel RO7239361 Whole Study
RO7239361 subcutaneous injections on specified days. The Panel 3 and Expansion Panel dose targets achievement of > 95% suppression in levels of free myostatin at trough after 5 weeks of weekly dosing. Panel 3 and Expansion body weight tier doses are =>15kg to =< 45kg at a dose of 35 mg /0.7 mL and =>45kg at a dose of 50 mg /1.0 mL
Units
Counts
Participants
OG00011
OG0017
OG0026
OG00319
Title
Denominators
Categories
Day 4
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0037
Title
Measurements
OG0001.178± 1.8833
OG0015.070± 0.9456
OG00212.606± 5.7623
OG003
Day 5
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0036
Day 8
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0037
Day 15
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
Day 22
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0036
Day 29
ParticipantsOG00011
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
Day 33
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG0037
Week 12
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00314
Week 24 (end of DB period)
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0037
Week 25 (Week 1 OL)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0038
Week 36 (Week 12 OL)
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00314
Week 48 (Week 24 OL)
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG00318
Week 60 (Week 36 OL)
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0033
Week 72 (Week 48 OL)
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0034
Week 84 (Week 60 OL)
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG00316
Week 108 (Week 84 OL)
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG00318
Week 132 (Week 108 OL)
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG00318
Week 144 (Week 120 OL)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 156 (Week 132 OL)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG00318
Week 156 (Week 132 OL: Day 1 PFS)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 156 (Week 132 OL: Week 12 PFS)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Week 168 (Week 144 OL: Day 1 PFS)
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0033
Week 168 (Week 144 OL: Day 8 PFS)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Week 168 (Week 144 OL: Week 12 PFS)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 180 (Week 156 OL)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0022
ParticipantsOG0030
Week 180 (Week 156 OL: Week 12 PFS)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 192 (Week 168 OL: Day 1 PFS)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 192 (Week 168 OL: Day 45 PFS)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 252 (Week 228 OL)
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG00317
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0052 events1 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
2 events
2 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG00611 events3 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
19 at risk
EG0041 events1 affected9 at risk
EG0053 events1 affected8 at risk
EG00614 events9 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events3 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
4 events
4 affected
19 at risk
EG00411 events4 affected9 at risk
EG0051 events1 affected8 at risk
EG0069 events8 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
3 events
3 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG00613 events6 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
2 events
1 affected
19 at risk
EG0046 events4 affected9 at risk
EG0050 events0 affected8 at risk
EG00613 events8 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
19 at risk
EG00423 events5 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
5 events
2 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0063 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0053 events2 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
6 events
5 affected
19 at risk
EG0041 events1 affected9 at risk
EG0052 events2 affected8 at risk
EG0068 events4 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0064 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected8 at risk
EG0065 events4 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events3 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
4 events
4 affected
19 at risk
EG0047 events4 affected9 at risk
EG0052 events1 affected8 at risk
EG00612 events7 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0051 events1 affected8 at risk
EG0064 events3 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
5 events
4 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG00625 events11 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0045 events4 affected9 at risk
EG0050 events0 affected8 at risk
EG0064 events4 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG00420 events7 affected9 at risk
EG0050 events0 affected8 at risk
EG0068 events6 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected9 at risk
EG0051 events1 affected8 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0043 events3 affected9 at risk
EG0050 events0 affected8 at risk
EG0064 events3 affected26 at risk
1 events
1 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events5 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0062 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0042 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0064 events4 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
19 events
7 affected
19 at risk
EG0043 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG00627 events9 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0051 events1 affected8 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
19 at risk
EG0041 events1 affected9 at risk
EG0055 events4 affected8 at risk
EG00611 events7 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG00613 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0043 events2 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events5 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
4 events
2 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0066 events4 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0065 events3 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
2 events
2 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected26 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0063 events2 affected26 at risk
0 events
0 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
1 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
2 events
1 affected
19 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected26 at risk
6017.978
± 23
OG0055020.000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
Participants
OG004
12
ParticipantsOG0051
Title
Measurements
OG0001258.746± 35
OG0013697.590± 20
OG0039957.352± 34
OG0049944.183± 24
OG0059980.000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
Participants
OG004
11
ParticipantsOG0051
Title
Measurements
OG0001640.052± 15
OG0014220.280± 32
OG00312383.747± 30
OG00413215.188± 24
OG005NA± NANot evaluable, no sample taken
Participants
OG004
12
ParticipantsOG0051
Title
Measurements
OG0002015.695± 32
OG0015107.668± 25
OG00314110.005± 34
OG00415094.455± 19
OG005NA± NANot evaluable, no sample taken
Participants
OG004
16
ParticipantsOG0051
Title
Measurements
OG0002179.385± 26
OG0016484.502± 19
OG00319332.421± 20
OG00418789.382± 18
OG00527800.000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
Participants
OG004
14
ParticipantsOG0051
Title
Measurements
OG0002438.595± 16
OG0016100.315± 25
OG0026340.000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
OG00319923.182± 41
OG00412580.299± 41
OG00526200.000± NAGeometric Coefficient of Variation not evaluable as only one participant was included at this dose and therefore there was no dispersion.
89.5
10.5
0
0
0
0
100.0
0
0
1121.8
± 526.45
Title
Measurements
OG0001356.6± 641.27
OG001421.4± 70.60
OG002321.3± 165.91
OG00358.3± 33.20
Title
Measurements
OG0001438.2± 809.18
OG001446.6± 108.81
OG002357.8± 166.27
OG00366.1± 39.07
Title
Measurements
OG0001014.2± 549.26
OG001522.7± 131.51
OG002479.2± 319.13
OG003206.8± 419.21
Title
Measurements
OG0001266.9± 611.27
OG001478.4± 111.44
OG002280.8± 148.53
OG00354.8± 61.85
Title
Measurements
OG0001317.1± 728.48
OG001382.4± 82.58
OG002284.8± 324.16
OG00335.3± 51.45
Title
Measurements
OG0001214.0± 676.80
OG001372.3± 79.97
OG002179.0± 137.39
OG00324.8± 27.24
Title
Measurements
OG0001141.4± 606.99
OG001291.1± 77.55
OG002115.7± 84.49
OG00324.3± 30.64
Title
Measurements
OG0001366.5± 631.28
OG001307.8± 97.84
OG002110.8± 49.80
OG00316.2± 11.60
Title
Measurements
OG0001194.0± 599.59
OG001297.1± 74.62
OG002160.8± 122.75
OG00323.4± 25.34
95.334
± 2.4477
Title
Measurements
OG0003.114± 20.3395
OG00146.506± 9.0917
OG00269.700± 10.3411
OG00394.545± 2.7608
Title
Measurements
OG00023.917± 31.1378
OG00138.411± 7.0320
OG00262.524± 9.7074
OG00384.797± 22.1958
Title
Measurements
OG0005.744± 18.6190
OG00140.763± 10.0071
OG00277.090± 6.2939
OG00396.488± 1.9665
Title
Measurements
OG0005.561± 11.7425
OG00151.836± 9.3488
OG00281.693± 5.7392
OG00397.927± 1.1259
Title
Measurements
OG00012.599± 16.1591
OG00152.926± 6.6001
OG00286.894± 2.9590
OG00398.202± 1.4590
Title
Measurements
OG00015.662± 17.3640
OG00161.796± 4.5760
OG00291.557± 2.6444
OG00397.042± 5.4443
Title
Measurements
OG0005.289± 15.5082
OG00160.254± 9.4283
OG00292.454± 1.7243
OG00398.415± 1.2882
Title
Measurements
OG0009.910± 17.8109
OG00163.790± 5.7031
OG00288.392± 5.1669
OG00397.921± 2.2143
14.696
± 5.7926
Title
Measurements
OG0002.119± 2.9826
OG0015.845± 2.5725
OG00214.856± 7.6131
OG00317.308± 7.5955
Title
Measurements
OG0004.924± 12.9975
OG0017.041± 2.3470
OG00219.906± 9.8664
OG00321.609± 11.0880
Title
Measurements
OG0000.613± 0.2102
OG00114.067± 7.1096
OG00229.229± 10.4929
OG00345.289± 18.7600
Title
Measurements
OG0001.326± 1.3410
OG00111.985± 4.8243
OG00236.811± 26.8560
OG00352.841± 21.5542
Title
Measurements
OG0001.593± 3.1007
OG00115.735± 4.2010
OG00243.236± 34.0300
OG00367.255± 27.9376
Title
Measurements
OG0001.157± 1.0036
OG00118.542± 3.9874
OG00246.279± 24.1457
OG00377.142± 32.4153
Title
Measurements
OG0007.082± 15.2289
OG00128.556± 22.7890
OG00279.555± 17.2126
OG00388.402± 29.8080
Title
Measurements
OG0003.589± 7.8108
OG00125.997± 6.4384
OG00283.262± 64.2281
OG003101.406± 45.4197
2.27
± 1.122
OG0042.36± 0.875
ParticipantsOG00411
Title
Measurements
OG0000.69± 0.104
OG0010.88± 0.283
OG0021.12± 0.281
OG0030.93± 0.255
OG0041.04± 0.101
ParticipantsOG00411
Title
Measurements
OG0000.78± 0.221
OG0010.94± 0.304
OG0021.57± 0.556
OG0031.10± 0.280
OG0041.26± 0.237
ParticipantsOG00411
Title
Measurements
OG0000.92± 0.269
OG0012.77± 1.144
OG0022.03± 1.564
OG0030.79± 0.162
OG0041.31± 0.301
Participants
OG004
11
Title
Measurements
OG0001.13± 0.318
OG0017.57± 5.372
OG0020.98± 0.176
OG0033.41± 2.474
OG0045.42± 3.871
ParticipantsOG00411
Title
Measurements
OG0000.74± 0.185
OG0010.55± 0.134
OG0024.49± 2.729
OG0030.99± 0.345
OG0042.02± 0.764
Participants
OG004
10
Title
Measurements
OG0001.78± 0.771
OG0010.69± 0.307
OG0021.04± 0.443
OG0030.90± 0.396
OG0042.00± 0.683
ParticipantsOG00413
Title
Measurements
OG0000.82± 0.230
OG0010.82± 0.284
OG0021.47± 0.777
OG0030.86± 0.276
OG0041.31± 0.194
ParticipantsOG00411
Title
Measurements
OG0000.78± 0.262
OG0012.95± 1.016
OG0021.31± 0.260
OG0031.42± 0.317
OG0041.17± 0.160
ParticipantsOG00410
Title
Measurements
OG0002.59± 1.749
OG0011.11± 0.292
OG0020.62± 0.258
OG0030.86± 0.157
OG0041.64± 0.377
ParticipantsOG00412
Title
Measurements
OG0000.66± 0.160
OG0010.89± 0.272
OG0021.10± 0.333
OG0031.78± 0.455
OG0041.70± 0.334
ParticipantsOG00412
Title
Measurements
OG0001.08± 0.269
OG0011.26± 0.112
OG0022.97± 1.981
OG0030.85± 0.280
OG0045.96± 3.376
ParticipantsOG00411
Title
Measurements
OG0000.81± 0.290
OG0011.14± 0.269
OG0021.11± 0.471
OG0031.36± 0.718
OG0042.41± 0.813
ParticipantsOG00411
Title
Measurements
OG0000.66± 0.112
OG0010.94± 0.296
OG0020.59± 0.144
OG0031.61± 0.697
OG0041.14± 0.146
ParticipantsOG00412
Title
Measurements
OG0001.07± 0.511
OG0011.13± 0.315
OG0021.00± 0.349
OG0031.29± 0.238
OG0042.10± 1.044
ParticipantsOG00412
Title
Measurements
OG0000.91± 0.195
OG0012.24± 1.027
OG0022.15± 1.003
OG0031.24± 0.411
OG0042.02± 0.416
Participants
OG004
9
Title
Measurements
OG0001.43± 0.686
OG0013.03± 2.564
OG0021.37± 0.465
OG0031.45± 0.748
OG0045.17± 3.540
ParticipantsOG00411
Title
Measurements
OG0000.94± 0.256
OG0010.84± 0.220
OG0027.43± 6.216
OG0030.80± 0.262
OG0043.01± 1.612
Participants
OG004
10
Title
Measurements
OG0001.90± 0.872
OG0010.73± 0.207
OG0020.78± 0.375
OG0033.24± 1.850
OG0042.45± 0.842
ParticipantsOG00412
Title
Measurements
OG0000.66± 0.126
OG0010.90± 0.361
OG0020.72± 0.157
OG0030.94± 0.250
OG0041.39± 0.256
ParticipantsOG00411
Title
Measurements
OG0000.56± 0.119
OG0011.59± 0.520
OG0021.43± 0.524
OG0031.04± 0.254
OG0041.22± 0.221
ParticipantsOG00410
Title
Measurements
OG0000.95± 0.412
OG0011.47± 0.446
OG0020.63± 0.355
OG0030.96± 0.095
OG0041.47± 0.318
ParticipantsOG00412
Title
Measurements
OG0000.78± 0.159
OG0011.88± 0.905
OG0021.45± 0.596
OG0031.43± 0.256
OG0042.03± 0.484
ParticipantsOG00412
Title
Measurements
OG0002.14± 0.889
OG0015.16± 3.580
OG0026.01± 5.478
OG0031.29± 0.474
OG0043.50± 1.390
14.61
± 9.755
OG00429.98± 8.530
ParticipantsOG00412
Title
Measurements
OG00031.01± 24.708
OG00124.12± 11.804
OG002-3.73± 29.037
OG00353.20± 25.328
OG0044.01± 54.787
ParticipantsOG00412
Title
Measurements
OG00034.24± 18.328
OG00133.43± 35.009
OG00216.72± 17.806
OG00319.22± 9.802
OG00423.93± 11.289
ParticipantsOG00412
Title
Measurements
OG00014.10± 7.724
OG0017.45± 11.592
OG0022.69± 13.733
OG00318.68± 7.479
OG0049.84± 3.882
Participants
OG004
12
Title
Measurements
OG00020.14± 15.489
OG00143.00± 28.539
OG00215.28± 8.693
OG00327.02± 5.686
OG00423.22± 5.440
ParticipantsOG00412
Title
Measurements
OG000-7.86± 14.391
OG00110.33± 11.927
OG002-3.56± 14.175
OG00334.91± 6.037
OG00416.01± 9.888
Participants
OG004
12
Title
Measurements
OG00011.26± 6.584
OG0016.59± 11.952
OG002-0.85± 6.383
OG00310.81± 11.017
OG00418.20± 5.519
ParticipantsOG00412
Title
Measurements
OG00039.11± 15.041
OG00132.57± 19.133
OG00216.56± 19.998
OG00346.70± 16.480
OG00431.01± 10.564
ParticipantsOG00412
Title
Measurements
OG00025.03± 9.409
OG001-1.24± 10.973
OG00233.00± 26.730
OG00336.69± 14.802
OG00440.10± 10.180
ParticipantsOG00412
Title
Measurements
OG00010.47± 12.160
OG00123.35± 12.704
OG002-52.03± 71.421
OG003-0.81± 19.353
OG00410.44± 7.344
ParticipantsOG00412
Title
Measurements
OG00031.47± 39.343
OG00138.32± 19.570
OG00214.08± 27.902
OG00357.86± 34.026
OG00422.73± 15.138
ParticipantsOG00412
Title
Measurements
OG000-17.89± 19.358
OG00115.65± 8.463
OG002-11.60± 15.849
OG00321.14± 9.746
OG00417.89± 6.788
ParticipantsOG00412
Title
Measurements
OG00011.69± 15.626
OG00123.41± 13.199
OG00212.81± 16.393
OG00317.15± 15.484
OG00444.12± 13.323
ParticipantsOG00412
Title
Measurements
OG00034.17± 24.918
OG00121.90± 12.345
OG002-6.71± 37.311
OG00345.05± 27.520
OG0044.41± 52.393
ParticipantsOG00412
Title
Measurements
OG00039.21± 19.760
OG00142.84± 22.086
OG002-5.32± 29.140
OG00333.70± 12.073
OG00431.33± 13.370
ParticipantsOG00412
Title
Measurements
OG00020.09± 9.818
OG00111.83± 13.013
OG002-0.44± 16.183
OG00330.01± 13.494
OG00418.60± 5.394
Participants
OG004
12
Title
Measurements
OG0008.14± 7.148
OG00118.72± 16.757
OG00211.21± 5.461
OG00348.95± 17.064
OG00440.15± 8.382
ParticipantsOG00412
Title
Measurements
OG0008.97± 10.214
OG0017.68± 13.082
OG002-10.01± 16.121
OG00355.65± 27.535
OG00438.40± 14.293
Participants
OG004
12
Title
Measurements
OG00010.75± 7.136
OG0010.81± 8.143
OG002-14.18± 9.481
OG00316.63± 4.476
OG00425.51± 6.404
ParticipantsOG00412
Title
Measurements
OG00045.83± 14.896
OG00130.01± 18.631
OG002-11.48± 24.468
OG00361.03± 25.524
OG00449.49± 12.011
ParticipantsOG00412
Title
Measurements
OG00032.00± 16.102
OG00136.17± 23.285
OG00224.16± 23.403
OG00373.68± 17.594
OG00462.55± 11.073
ParticipantsOG00412
Title
Measurements
OG00014.86± 15.072
OG00143.01± 11.506
OG002-68.05± 86.362
OG00341.63± 34.926
OG00422.55± 8.284
ParticipantsOG00412
Title
Measurements
OG00012.95± 35.465
OG00147.79± 26.178
OG00232.64± 30.136
OG00345.41± 43.774
OG00446.87± 20.919
ParticipantsOG00412
Title
Measurements
OG000-9.09± 11.856
OG0019.82± 6.965
OG002-13.74± 29.664
OG00310.46± 12.093
OG00423.94± 11.321
421.4
± 70.60
OG001321.3± 165.91
OG00258.3± 33.20
446.6
± 108.81
OG001357.8± 166.27
OG00266.1± 39.07
522.7
± 131.51
OG001479.2± 319.13
OG002206.8± 419.21
478.4
± 111.44
OG001280.8± 148.53
OG00254.8± 61.85
382.4
± 82.58
OG001284.8± 324.16
OG00235.3± 51.45
372.3
± 79.97
OG001179.0± 137.39
OG00224.8± 27.24
291.1
± 77.55
OG001115.7± 84.49
OG00224.3± 30.64
394.0
± 179.78
OG001115.0± 62.23
OG00218.1± 13.37
357.9
± 137.56
OG001139.1± 111.63
OG00223.0± 23.68
331.0
± 116.78
OG001154.5± 115.21
OG00222.8± 18.48
340.3
± 98.24
OG00181.4± 36.00
OG00221.1± 22.03
401.3
± 233.76
OG00179.0± 37.85
OG00218.6± 12.11
284.6
± 96.92
OG00190.4± 39.30
OG00236.3± 54.13
326.8
± 151.29
OG001132.0± 146.37
OG002205.7± 321.58
534.0
± 260.31
OG00174.2± 13.58
OG002115.6± 146.44
320.9
± 222.10
OG00184.4± 61.19
OG00240.2± 42.70
283.5
± 103.73
OG00171.0± 40.02
OG00240.2± 38.26
95.2
± NA
NA: SD not calculable for 1 participant
208.7
± 64.52
OG00148.9± 22.42
OG00220.0± 0.00
212.5
± 146.37
20.0
± NA
NA: SD not calculable for 1 participant
46.506
± 9.0917
OG00169.700± 10.3411
OG00294.545± 2.7608
38.411
± 7.0320
OG00162.524± 9.7074
OG00284.797± 22.1958
40.763
± 10.0071
OG00177.090± 6.2939
OG00296.488± 1.9665
51.836
± 9.3488
OG00181.693± 5.7392
OG00297.927± 1.1259
52.926
± 6.6001
OG00186.894± 2.9590
OG00298.202± 1.4590
61.796
± 4.5760
OG00191.557± 2.6444
OG00297.042± 5.4443
58.934
± 8.7345
OG00192.025± 2.0548
OG00298.208± 1.5605
63.199
± 5.3419
OG00189.664± 5.0245
OG00298.009± 1.8677
62.446
± 7.0668
OG00188.689± 4.8868
OG00297.974± 1.8259
64.103
± 5.3774
OG00192.057± 2.6300
OG00298.470± 0.8410
58.161
± 15.7101
OG00192.237± 3.4952
OG00298.036± 1.4516
66.280
± 8.4684
OG00190.974± 2.1780
OG00297.177± 2.8783
65.956
± 8.2066
OG00192.536± 2.4445
OG00279.193± 31.9504
54.990
± 11.0397
OG00192.328± 5.7945
OG00289.744± 13.0990
70.498
± 15.2905
OG00192.412± 3.3662
OG00295.884± 3.5214
71.129
± 4.9576
OG00192.935± 3.8121
OG00296.713± 2.4278
94.732
± NA
NA: SD not calculable for 1 participant
74.712
± 5.7764
OG00194.881± 1.3726
OG00298.183± 0.8086
75.374
± 9.5968
96.283
± NA
NA: SD not calculable for 1 participant
14.696
± 5.7926
Title
Measurements
OG0002.119± 2.9826
OG0015.845± 2.5725
OG00214.856± 7.6131
OG00317.308± 7.5955
Title
Measurements
OG0004.924± 12.9975
OG0017.041± 2.3470
OG00219.906± 9.8664
OG00321.609± 11.0880
Title
Measurements
OG0000.613± 0.2102
OG00114.067± 7.1096
OG00229.229± 10.4929
OG00345.289± 18.7600
Title
Measurements
OG0001.326± 1.3410
OG00111.985± 4.8243
OG00236.811± 26.8560
OG00352.841± 21.5542
Title
Measurements
OG0001.593± 3.1007
OG00115.735± 4.2010
OG00243.236± 34.0300
OG00367.255± 27.9376
Title
Measurements
OG0001.157± 1.0036
OG00118.542± 3.9874
OG00246.279± 24.1457
OG00377.142± 32.4153
Title
Measurements
OG0007.082± 15.2289
OG00128.556± 22.7890
OG00279.555± 17.2126
OG00388.402± 29.8080
Title
Measurements
OG0003.589± 7.8108
OG00125.997± 6.4384
OG00283.262± 64.2281
OG003101.406± 45.4197
Title
Measurements
OG0003.186± 6.9734
OG00131.963± 8.0240
OG00277.926± 56.9987
OG003102.211± 40.2284
Title
Measurements
OG00095.788± 88.1521
OG00122.584± 8.6839
OG00257.164± 25.8284
OG003101.234± 42.0902
Title
Measurements
OG00090.593± 73.7102
OG00127.461± 7.2306
OG003103.657± 45.8802
Title
Measurements
OG00063.358± 37.5591
OG00141.779± 34.2407
OG00289.712± 38.9214
OG00367.163± 8.4904
Title
Measurements
OG00092.086± 68.5222
OG00126.740± 3.0256
OG0020.550± NANA: SD not calculable for 1 participant
OG003102.025± 31.4717
Title
Measurements
OG000146.950± 131.3706
OG00127.110± 3.2527
OG003117.719± 41.1143
Title
Measurements
OG000122.610± 87.1911
OG00136.014± 10.9338
OG00266.020± 7.2878
OG003114.806± 32.7432
Title
Measurements
OG00095.811± 48.1440
OG00132.133± 8.2848
OG00275.040± 14.3015
OG003107.378± 37.8814
Title
Measurements
OG00125.600± NANA: SD not calculable for 1 participant
Title
Measurements
OG00095.529± 48.0065
OG00130.186± 7.0053
OG00269.325± 17.7064
OG003108.100± 35.5833
Title
Measurements
OG00064.400± 0.5657
Title
Measurements
OG000152.000± NANA: SD not calculable for 1 participant
OG003125.583± 44.4144
Title
Measurements
OG000105.700± 54.5772
OG00270.100± 25.1213
OG003122.633± 91.2542
Title
Measurements
OG003119.000± NANA: SD not calculable for 1 participant
Title
Measurements
OG00294.900± NANA: SD not calculable for 1 participant
Title
Measurements
OG00045.933± 28.3161
OG00125.589± 12.2478
OG002103.300± 16.5463
Title
Measurements
OG00162.600± NANA: SD not calculable for 1 participant
Title
Measurements
OG00118.000± NANA: SD not calculable for 1 participant
Title
Measurements
OG00180.400± NANA: SD not calculable for 1 participant