An 8-Week Dose-Finding Study to Evaluate the Efficacy and... | NCT02890992 | Trialant
NCT02890992
Sponsor
Sanofi
Status
Completed
Last Update Posted
Sep 6, 2019Actual
Enrollment
42Actual
Phase
Phase 2
Conditions
Hypercholesterolaemia
Interventions
alirocumab SAR236553 (REGN727)
statins
ezetimibe
cholestyramine
fenofibrate
omega-3 fatty acids
nicotinic acid
Countries
United States
Canada
Czechia
France
Netherlands
Norway
Russia
South Africa
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT02890992
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DFI14223
Secondary IDs
ID
Type
Description
Link
2015-003766-85
EudraCT Number
U1111-1178-4764
Other Identifier
UTN
Brief Title
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Official Title
An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase
Acronym
ODYSSEY KIDS
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Aug 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 15, 2016Actual
Primary Completion Date
Sep 13, 2018Actual
Completion Date
Feb 22, 2019Actual
First Submitted Date
Aug 31, 2016
First Submission Date that Met QC Criteria
Aug 31, 2016
First Posted Date
Sep 7, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 15, 2019
Results First Submitted that Met QC Criteria
Aug 15, 2019
Results First Posted Date
Sep 6, 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
Aug 15, 2019
Last Update Posted Date
Sep 6, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Name
Class
Regeneron Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary Objective:
To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.
Secondary Objective:
To evaluate the safety and tolerability of alirocumab.
To evaluate the pharmacokinetics profile of alirocumab.
To evaluate the effects of alirocumab on other lipid parameters.
Detailed Description
For Cohorts 1 to 3, a study duration of approximately 16-23 weeks (screening period: up to 6 (+1) weeks, open-label dose finding treatment period: 8 weeks, follow up period: 6-8 weeks).
For Cohort 4, a study duration of approximately 14-19 weeks (screening period up to 6 [+1] weeks, open-label dose finding treatment period: 12 weeks).
Optional extension period: up to a maximum of 2 years for the first participants enrolled in Cohorts 1 to 3, but a maximum of approximately 5 months for the first participants enrolled in Cohort 4.
For all participants who declined participation in the phase 3 study, their last alirocumab injection was on December 2018.
Conditions Module
Conditions
Hypercholesterolaemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
42Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Experimental
Period 1: Participants with body weight less than (<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram(mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until they started receiving dose matching to Cohort 2 dosage including dose adjustment to body weight as required. Cohort 2 dosage was: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Experimental
Period 1: Participants with body weight greater than or equal to (>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Experimental
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
alirocumab SAR236553 (REGN727)
Drug
Pharmaceutical form: solution Route of administration: subcutaneous injection
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
Percent change in calculated LDL-C was defined as 100*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period & within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 & 2) or +35 days (for Cohorts 3 & 4). Adjusted Least-squares (LS) mean & standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W [<50 kg], 40 mg Q2W [<50 kg], 50 mg Q2W [>=50 kg], 75 mg Q2W [>=50 kg], 75 mg Q4W [<50 kg],150 mg Q4W [>=50 kg], 150 mg Q4W [<50 kg] and 300 mg Q4W ([>=50 kg] dose), time point & dose/dose regimen-by-time point interaction.
Baseline, Week 8
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Baseline, Week 8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria :
Children and adolescent male and female participants aged of 8 to 17 years at the time of signed informed consent. For Russia only: Male and female participants aged >=12 and <=17 years at the time of signed informed consent.
Participants with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
Participants with calculated LDL-C greater than or equal to 130 mg/dL (>=3.37 mmol/L) at the screening visit.
Participants with body weight greater than or equal to 25 kg.
Participants aged of 8 to 9 years to be at Tanner stage 1 and participants aged of 10 to 17 years to be at least at Tanner stage 2 in their development.
A signed informed consent indicating parental permission with or without participant assent.
Exclusion criteria:
Participant with secondary hyperlipidemia.
Diagnosis of homozygous familial hypercholesterolemia.
Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
Known history of type 1 or type 2 diabetes mellitus.
Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May-Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 42 participants were included in this study.
Recruitment Details
The study was conducted at 16 sites in 10 countries. Overall 63 participants were screened between 15 September 2016 and 13 June 2018, of whom 21 participants were screen failures. Screen failures were mainly due to exclusion criteria met.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Period 1: Participants with body weight less than (<) 50 kilograms (kg) received subcutaneous (SC) injection of alirocumab 30 milligram (mg) administered every 2 weeks (Q2W) up to 8 weeks added to lipid modifying therapy (LMT).
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
Periods
Title
Milestones
Reasons Not Completed
12 Weeks Open-Label Dose Finding Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 11, 2017
Aug 15, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Experimental
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Experimental
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Experimental
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Experimental
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Experimental
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
Drug: alirocumab SAR236553 (REGN727)
Drug: statins
Drug: ezetimibe
Drug: cholestyramine
Drug: fenofibrate
Drug: omega-3 fatty acids
Drug: nicotinic acid
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Praluent
statins
Drug
Pharmaceutical form: tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
ezetimibe
Drug
Pharmaceutical form:tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
cholestyramine
Drug
Pharmaceutical form:tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
fenofibrate
Drug
Pharmaceutical form: tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
omega-3 fatty acids
Drug
Pharmaceutical form: tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
nicotinic acid
Drug
Pharmaceutical form: tablet Route of administration: oral
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
At Week 8
Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
At Week 8
Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4
Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Baseline, Week 12
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.
Baseline, Week 8
Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Percent Change From Baseline in Lipoprotein(a) at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Baseline, Week 8
Percent Change From Baseline in Fasting Triglyceride at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Baseline, Week 8
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Percent Change From Baseline in Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Apolipoprotein B at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Lipoprotein(a) at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Baseline, Week 8
Absolute Change From Baseline in HDL-C at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Fasting Triglyceride at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Baseline, Week 8
Absolute Change From Baseline in Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Baseline, Week 8
Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Period 1: Participants with body weight greater than or equal to (>=) 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
FG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
FG003
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
FG004
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
FG005
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
FG006
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of Alirocumab 150 mg administered Q4W from Week 12 until Week 48.
FG007
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
FG0004 subjects
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
FG0075 subjects
Treated
FG0004 subjects
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
FG0075 subjects
COMPLETED
FG0004 subjectsOut of 4 participants, 3 participants entered into the open-label extension (OLE) period.
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
FG0075 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
130 Weeks Open-Label Extension Period
Type
Comment
Milestone Data
STARTED
FG0003 subjects3 participants from Open-Label Dose Finding Period (OLDFI) entered in OLE period.
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
FG0075 subjects
Treated
FG0003 subjects
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG004
COMPLETED
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Analysis was performed on safety population that included population who did actually received at least one dose or part of a dose of the open-label investigational medicinal product (IMP). Participants were analyzed according to the dose of alirocumab actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W from Week 16 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
BG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W from Week 16 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
BG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W from Week 16 until switch of dosage in Cohorts 1 and 3. If body weight was still < 50 kg, participants continued to receive SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
BG003
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W from Week 16 until Week 130.
BG004
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered every 4 weeks (Q4W) up to 8 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W from Week 14 until switch to Cohort 2 dosage including dose adjustment to body weight as required, then Cohort 2 dosage: if body weight was still < 50 kg, participants received SC injection of alirocumab 40 mg administered Q2W until Week 130; if body weight was > = 50 kg participants received SC injection of alirocumab 75 mg administered Q2W until Week 130.
BG005
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 14 until switch to Cohort 2 dosage then SC injection of alirocumab 75 mg administered Q2W until Week 130.
BG006
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Period 1: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W from Week 12 until Week 48.
BG007
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Period 1: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Period 2: Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W from Week 12 until Week 48.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0016
BG0024
BG0036
BG0046
BG0055
BG0066
BG0075
BG00842
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
BG00011.0± 2.0
BG00113.8± 2.7
BG00211.3± 2.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0000
BG0010
BG002
Low Density Lipoprotein Cholesterol (LDL-C)
Mean
Standard Deviation
millimoles per litre (mmol/L)
Title
Denominators
Categories
Title
Measurements
BG0005.169± 0.736
BG0014.339± 1.200
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
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
Percent change in calculated LDL-C was defined as 100*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period & within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 & 2) or +35 days (for Cohorts 3 & 4). Adjusted Least-squares (LS) mean & standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W [<50 kg], 40 mg Q2W [<50 kg], 50 mg Q2W [>=50 kg], 75 mg Q2W [>=50 kg], 75 mg Q4W [<50 kg],150 mg Q4W [>=50 kg], 150 mg Q4W [<50 kg] and 300 mg Q4W ([>=50 kg] dose), time point & dose/dose regimen-by-time point interaction.
Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose or partial dose of IMP injection and had an evaluable outcome measure during the open-label dose finding efficacy treatment period.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to 8 weeks added to LMT.
OG004
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to 8 weeks added to LMT.
OG005
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to Week 8 added to LMT.
OG006
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
Units
Counts
Participants
OG0004
OG0016
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG000-41.1± 12.6
OG001-7.9± 10.3
OG002-40.6± 13.2
OG003
Secondary
Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8
Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
milligram per deciliter (mg/dL)
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8
Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram (mg) administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4
Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.
Analysis was performed on mITT population. Data for this outcome measure was planned to be collected for Cohort 4 only.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 12
ID
Title
Description
OG000
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to 12 weeks added to LMT.
OG001
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to 12 weeks added to LMT.
Units
Counts
Participants
OG000
Secondary
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.
Analysis was performed on mITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 milligram(mg) administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Percent Change From Baseline in Lipoprotein(a) at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Secondary
Percent Change From Baseline in Fasting Triglyceride at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Percent Change From Baseline in Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Absolute Change From Baseline in Apolipoprotein B at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Secondary
Absolute Change From Baseline in Lipoprotein(a) at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
gram/Liter (g/L)
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Secondary
Absolute Change From Baseline in HDL-C at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
OG003
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Secondary
Absolute Change From Baseline in Fasting Triglyceride at Week 8
Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.
Analysis was performed on mITT population.
Posted
Least Squares Mean
Standard Error
mmol/L
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Secondary
Absolute Change From Baseline in Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Secondary
Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8
Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.
Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.
Posted
Least Squares Mean
Standard Error
ratio (Apo B/Apo A-1)
Baseline, Week 8
ID
Title
Description
OG000
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to 8 weeks added to LMT.
OG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to 8 weeks added to LMT.
OG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to 8 weeks added to LMT.
Time Frame
All Adverse Events (AEs) were collected from the time of first dose of IMP up to the end of study (Week 152) regardless of seriousness or relationship to investigational product.
Description
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). Participants from Cohorts 1, 2 and 3 had an option to switch to cohort 2 dosage according to their weight category. 7 participants from Cohort 1 and 11 participants from Cohort 2 and 3 switched the dosage. Analysis was performed on safety population.
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
Cohort 1 - Alirocumab 30 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 30 mg administered Q2W up to the switch of dosage added to LMT.
0
4
0
4
4
4
EG001
Cohort 1 - Alirocumab 50 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 50 mg administered Q2W up to the switch of dosage added to LMT.
0
6
0
6
5
6
EG002
Cohort 2 - Alirocumab 40 mg Q2W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 40 mg administered Q2W up to the switch of dosage added to LMT.
0
4
0
4
1
4
EG003
Cohort 2 - Alirocumab 75 mg Q2W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 75 mg administered Q2W up to the switch of dosage added to LMT.
0
6
0
6
4
6
EG004
Cohort 3 - Alirocumab 75 mg Q4W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 75 mg administered Q4W up to the switch of dosage added to LMT.
0
6
0
6
5
6
EG005
Cohort 3 - Alirocumab 150 mg Q4W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the switch of dosage added to LMT.
0
5
0
5
3
5
EG006
Cohort 4 - Alirocumab 150 mg Q4W: <50 kg
Participants with body weight < 50 kg received SC injection of alirocumab 150 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
0
6
0
6
3
6
EG007
Cohort 4 - Alirocumab 300 mg Q4W: >=50 kg
Participants with body weight >= 50 kg received SC injection of alirocumab 300 mg administered Q4W up to the end of the OLE period (up to 130 weeks) added to LMT.
0
5
0
5
4
5
EG008
Alirocumab 40 Q2W Post-switch
Participants with body weight < 50 kg from cohort 1, 2 and 3 switched to dosage and received SC injection of alirocumab 40 mg administered Q2W from the switch up to the end of the OLE period (up to 130 weeks) added to LMT.
0
10
0
10
7
10
EG009
Alirocumab 75 Q2W Post-switch
Participants from Cohort 1 (7 participants), Cohort 2 and Cohort 3 (11 participants) switched to dosage and received SC injection of alirocumab 75 mg administered Q2W up to the end of the OLE period (up to 130 weeks) added to LMT.
0
18
0
18
9
18
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected5 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected18 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Excessive Eye Blinking
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0014 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Injection Site Reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Food Allergy
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis Bacterial
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cytomegalovirus Hepatitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Infectious Mononucleosis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0015 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Otitis Media
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Pharyngitis Streptococcal
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Varicella
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Animal Scratch
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Post-Traumatic Pain
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood Follicle Stimulating Hormone Decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood Luteinising Hormone Decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Low Density Lipoprotein Decreased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Type 1 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tendon Pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pyogenic Granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Thoracic Outlet Syndrome
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Alcohol Abuse
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety Disorder
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Premenstrual Pain
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pallor
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 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 Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.