The BROADEN Study: A Study of Volanesorsen (Formerly IONI... | NCT02527343 | Trialant
NCT02527343
Sponsor
Akcea Therapeutics
Status
Terminated
Last Update Posted
Oct 18, 2021Actual
Enrollment
40Actual
Phase
Phase 2Phase 3
Conditions
Familial Partial Lipodystrophy
Interventions
volanesorsen
Placebo
Countries
United States
Belgium
Brazil
Canada
Germany
Netherlands
Russia
Protocol Section
Identification Module
NCT ID
NCT02527343
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ISIS 304801-CS17
Secondary IDs
ID
Type
Description
Link
2015-000493-35
EudraCT Number
Brief Title
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy
Official Title
A Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial Lipodystrophy
Acronym
Not provided
Organization
Akcea TherapeuticsINDUSTRY
Status Module
Record Verification Date
Sep 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated early at a time point when sufficient data had been accumulated to inform a decision on further development of volanesoresen in participants with FPL.
Expanded Access Info
No
Start Date
Dec 28, 2015Actual
Primary Completion Date
Jun 30, 2018Actual
Completion Date
Nov 13, 2019Actual
First Submitted Date
Aug 17, 2015
First Submission Date that Met QC Criteria
Aug 18, 2015
First Posted Date
Aug 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 3, 2021
Results First Submitted that Met QC Criteria
Sep 21, 2021
Results First Posted Date
Oct 18, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 7, 2020
Certification/Extension First Submitted that Passed QC Review
Jan 7, 2020
Certification/Extension First Posted Date
Jan 10, 2020Actual
Last Update Submitted Date
Sep 21, 2021
Last Update Posted Date
Oct 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Akcea TherapeuticsINDUSTRY
Collaborators
Name
Class
Ionis Pharmaceuticals, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.
Detailed Description
Not provided
Conditions Module
Conditions
Familial Partial Lipodystrophy
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
40Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo/Volanesorsen
Experimental
Randomized Period: Volanesorsen-matching placebo as SC, QW for Weeks 1-52. Participants who received volanesorsen-matching placebo in RT period and not enter in OLE period went straight to 13-week PT follow-up period. Dose adjustment based on monitoring rules were allowed.
OLE Period: Participants who received volanesorsen-matching placebo in RT period and completed RT period, were to receive 300 mg of volanesorsen as SC QW for 52 weeks (Weeks 53-104) in OLE period. Dose adjustment based on monitoring rules were allowed. After Week 104, participants had option of continuing treatment with 300 mg of volanesorsen as SC injection for up to additional 52 weeks (Weeks 105-156). Participants not entered in option for additional 52 weeks of dosing in OLE PT period went straight to 13-week PT follow-up period after completion of first 52 weeks (Weeks 53-104) of OLE. Participants entered in OLE PT period went straight to 13-week PT follow-up period after completion of Week 156 of OLE.
Drug: volanesorsen
Drug: Placebo
Volanesorsen
Experimental
Randomized Period: 300 mg of volanesorsen as SC, QW for Weeks 1-52. Participants who received 300 mg of volanesorsen in RT period and did not enter in OLE period went straight to 13-week PT follow-up period. Dose adjustment based on monitoring rules were allowed.
OLE Period: Participants who received volanesorsen in RT period and completed RT period, were to receive 300 mg of volanesorsen as SC QW for 52 weeks (Weeks 53-104) in OLE period. Dose adjustment based on monitoring rules were allowed. After Week 104, participants had option of continuing treatment with 300 mg of volanesorsen as SC injection for up to additional 52 weeks (Week 105-156). Participants who were not entered in option for additional 52 weeks of dosing in OLE PT period went straight to 13-week PT follow-up period after completion of first 52 weeks (Weeks 53-104) of OLE. Participants entered in OLE PT period went straight to 13-week PT follow-up period after completion of Week 156 of OLE.
Drug: volanesorsen
Interventions
Name
Type
Description
Arm Group Labels
Other Names
volanesorsen
Drug
300 mg of volanesorsen administered subcutaneous (SC) injection, once-weekly (QW).
Placebo/Volanesorsen
Volanesorsen
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Randomized Treatment Period: Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG)
Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 predose fasting assessment. Month 3 value was defined as the average of Week 12 and Week 13 fasting TG assessments of the randomized treatment period. The data was analyzed using an analysis of covariance (ANCOVA) model with the randomization stratification factor (diagnosis of disease with or without genetics and family history) and treatment group as factors and log-transformed baseline fasting TG as a covariate.
Baseline to Month 3
Secondary Outcomes
Measure
Description
Time Frame
Randomized Treatment Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using Magnetic Resonance Imaging (MRI)
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Randomized treatment period: Month 6 value was defined as Week 25 or Week 26 for MRI assessment and Month 12 was defined as Week 50 or Week 52 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must give written informed consent to participate in the study (signed and dated) and any authorizations required by law.
Clinical diagnosis of familial partial lipodystrophy (FPL) plus diagnosis of type 2 diabetes mellitus, hypertriglyceridemia, and fatty liver.
Diagnosis of FPL is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (less than or equal to [≤] 10 millimeters [mm]) and women (≤ 22 mm), and at least 1 of the following:
Genetic diagnosis of FPL OR
Family history of FPL or of similar abnormal fat distribution plus 1 Minor Criteria OR
In the absence of FPL-associated genetic variant or family history, 2 Minor Criteria and body mass index (BMI) less than (<) 35 kilogram per meter square (kg/m^2).
Diabetes not well controlled on antidiabetic therapy with glycated hemoglobin (Hb) HbA1c more than or equal to (≥) 7 percentage (%) to ≤ 12% at Screening.
Hypertriglyceridemia with fasting triglycerides (TG) levels greater than or equal to (≥) 500 milligrams per deciliter (mg/dL) (≥ 5.7 millimoles per liter [mmol/L]) at Screening and Qualification visit, or Fasting TG levels ≥ 200 (≥ 2.26 mmol/L) at both Screening and Qualification Visits for participants who meet the genetic or family history criteria.
Presence of hepatosteatosis (fatty liver), as evidenced by a screening magnetic resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%.
Exclusion Criteria:
A diagnosis of generalized lipodystrophy.
A diagnosis of acquired partial lipodystrophy.
Acute pancreatitis within 4 weeks of Screening.
History within 6 months of Screening of acute or unstable cardiac condition.
Low-density lipoprotein cholesterol (LDL-C) more than (>) 130 mg/dL on maximal tolerated statin therapy.
Platelet count < lower limit of normal (LLN).
Treatment with metreleptin within the last 3 months prior to Screening.
Prohaska TA, Alexander VJ, Karwatowska-Prokopczuk E, Tami J, Xia S, Witztum JL, Tsimikas S. APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia. J Clin Lipidol. 2023 May-Jun;17(3):406-411. doi: 10.1016/j.jacl.2023.04.007. Epub 2023 Apr 27.
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 40 participants were randomized into this study.
Recruitment Details
The study was conducted at 12 study centers in the United States, Russia, Brazil, Germany, Belgium, Canada, and Netherlands from 28 December 2015 to 13 November 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a subcutaneous (SC) injection once-weekly from Weeks 1 to 52 of the randomized treatment (RT) period. Participants were allowed dose adjustment based on monitoring rules.
Open-Label Extension Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using MRI
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Open-label extension period: Month 6 value was defined as Week 77 or Week 78 for MRI assessment and Month 12 value was defined as Week 102 or Week 104 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
Baseline, Months 6 and 12
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: The Month 3 value was defined as Week 13, Month 6 value was defined as Week 26, Month 9 value was defined as Week 38 and Month 12 value was defined as Week 52.
Baseline, Months 3, 6, 9, and 12
Open Label Extension Period: Change From Baseline in HbA1c
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Open-label extension period: Month 3 value was defined as Week 65, Month 6 value was defined as Week 78, Month 9 value was defined as Week 90 and Month 12 value was defined as Week 104.
Baseline, Months 3, 6, 9, and 12
Randomized Treatment Period: Percentage of Participants Who Achieved Greater Than or Equal to (≥) 40% Reduction in Fasting Triglyceride and ≥ 30% Reduction of Hepatic Fat Fraction at Month 6
The baseline of TG is defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. The baseline of hepatic fat fraction is defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: Month 6 value was defined as average of Week 25 and Week 26 for fasting TG and Week 25 or Week 26 for hepatic fat fraction.
Month 6
Randomized Treatment Period: Change From Baseline in Disease Burden Score
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
From the first dose of study drug to Week 52
Open-Label Extension Period: Change From Baseline in Disease Burden Score
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
From the first dose of study drug in open label extension period to Week 117
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
From the first dose of study drug up to Week 52
Open Label Extension Period: Patient-Reported Pain
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
From the first dose of study drug in open label extension period up to Week 117
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
From the first dose of study drug up to Week 52
Open Label Extension Period: Patient-Reported Hunger
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
From the first dose of study drug in open label extension period up to Week 117
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
Baseline, Weeks 13, 26 and 52
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
Baseline, Weeks 65, 78 and 104
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
Baseline, Weeks 13, 26 and 52
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
Baseline, Weeks 65, 78 and 104
Rochester
Minnesota
55905
United States
IONIS Investigative Site
St Louis
Missouri
63110
United States
IONIS Investigative Site
Morehead City
North Carolina
28557
United States
IONIS Investigative Site
Philadelphia
Pennsylvania
19104
United States
IONIS Investigative Site
Dallas
Texas
75390
United States
IONIS Investigative Site
Leuven
3000
Belgium
IONIS Investigative Site
Rio de Janeiro
20211-340
Brazil
IONIS Investigative Site
Halifax
Nova Scotia
B3H 1C2
Canada
IONIS Investigative Site
Münster
48149
Germany
IONIS Investigative Site
Amsterdam-Zuidoost
1105 AZ
Netherlands
IONIS Investigative Site
Moscow
117036
Russia
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period.
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
FG004
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
FG005
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
FG00019 subjects
FG00121 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00013 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0006 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Investigator Judgement
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Voluntary withdrawal
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event (AE) or Serious Adverse Event (SAE)
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
Other
FG0004 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
RT Post Treatment Follow-up: Weeks 54-65
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0027 subjectsOnly those participants who were entered in the 13-week post-treatment follow-up period after the randomized treatment period.
FG0039 subjectsOnly those participants who were entered in the 13-week post-treatment follow-up period after the randomized treatment period.
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
AE or SAE
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
OLE Period-Year 1: Week 53 to 104
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00412 subjectsOnly those participants who were entered the in the OLE period (first OLE period) after the randomized treatment period.
FG00512 subjectsOnly those participants who were entered the in the OLE period (first OLE period) after the randomized treatment period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Investigator Judgement
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
OLE Period-Year 2: Week 105 to 156
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjectsOnly those participants who were continuing the dosing for up to an additional 52 weeks in the second OLE period.
FG0052 subjectsOnly those participants who were continuing the dosing for up to an additional 52 weeks in the second OLE period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
PT Follow-up: Weeks 104 to 169
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00412 subjectsParticipants who were entered in the post-treatment follow-up after the OLE Period.
FG00512 subjectsParticipants who were entered in the post-treatment follow-up after the OLE Period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Voluntary withdrawal
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting triglyceride (TG) assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
BG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00121
BG00240
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
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG00240
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG002
Fasting Triglycerides
Mean
Standard Deviation
milligrams per deciliter (mg/dL)
Title
Denominators
Categories
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG002
Hepatic Fat Fraction
Number analyzed signifies the number of participants with data available for hepatic fat fraction.
Mean
Standard Deviation
percentage (Hepatic Fat Fraction)
Title
Denominators
Categories
ParticipantsBG00016
ParticipantsBG00117
ParticipantsBG002
Hemoglobin A1c
Mean
Standard Deviation
percentage of HbA1c
Title
Denominators
Categories
ParticipantsBG00019
ParticipantsBG00121
ParticipantsBG002
Short Form-36 (SF-36) Weighted Sum of Scores
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life.
Number analyzed signifies the number of participants with data available for SF-36 weighted sum of scores.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00016
ParticipantsBG001
EQ-5D Questionnaires: Index Scores
EQ-5D-5L is a standardized health-related quality of life questionnaire. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state.
Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: Index Scores.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG001
EQ-5D Questionnaires: Visual Analog Scale
EQ-5D-5L is a standardized health-related quality of life questionnaire EQ-5D-5L consists of two components: a health state profile and Visual Analog Scale (VAS). EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: VAS.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG001
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
Randomized Treatment Period: Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG)
Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 predose fasting assessment. Month 3 value was defined as the average of Week 12 and Week 13 fasting TG assessments of the randomized treatment period. The data was analyzed using an analysis of covariance (ANCOVA) model with the randomization stratification factor (diagnosis of disease with or without genetics and family history) and treatment group as factors and log-transformed baseline fasting TG as a covariate.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. This outcome measure is reported here for the randomized treatment period only, as per the planned analysis.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline to Month 3
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Units
Counts
Participants
OG00019
OG00121
Title
Denominators
Categories
Title
Measurements
OG000-21.64(-60.85 to 17.57)
OG001-88.47(-133.56 to -43.38)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0009
Difference in Least Square Mean
-66.83
2-Sided
95
-104.17
-29.48
Superiority
Secondary
Randomized Treatment Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using Magnetic Resonance Imaging (MRI)
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Randomized treatment period: Month 6 value was defined as Week 25 or Week 26 for MRI assessment and Month 12 was defined as Week 50 or Week 52 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline, Months 6 and 12
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Secondary
Open-Label Extension Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using MRI
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Open-label extension period: Month 6 value was defined as Week 77 or Week 78 for MRI assessment and Month 12 value was defined as Week 102 or Week 104 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
percent change
Baseline, Months 6 and 12
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
OG001
Secondary
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: The Month 3 value was defined as Week 13, Month 6 value was defined as Week 26, Month 9 value was defined as Week 38 and Month 12 value was defined as Week 52.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment.
Posted
Least Squares Mean
95% Confidence Interval
percentage of HbA1c
Baseline, Months 3, 6, 9, and 12
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Units
Counts
Secondary
Open Label Extension Period: Change From Baseline in HbA1c
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Open-label extension period: Month 3 value was defined as Week 65, Month 6 value was defined as Week 78, Month 9 value was defined as Week 90 and Month 12 value was defined as Week 104.
FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
percentage of HbA1c
Baseline, Months 3, 6, 9, and 12
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Secondary
Randomized Treatment Period: Percentage of Participants Who Achieved Greater Than or Equal to (≥) 40% Reduction in Fasting Triglyceride and ≥ 30% Reduction of Hepatic Fat Fraction at Month 6
The baseline of TG is defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. The baseline of hepatic fat fraction is defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: Month 6 value was defined as average of Week 25 and Week 26 for fasting TG and Week 25 or Week 26 for hepatic fat fraction.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. This outcome measure is reported here for the randomized treatment period only, as per the planned analysis.
Posted
Number
percentage of participants
Month 6
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Secondary
Randomized Treatment Period: Change From Baseline in Disease Burden Score
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
Data for this outcome measure was not collected due to the change in planned analysis.
Posted
From the first dose of study drug to Week 52
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Units
Counts
Participants
Secondary
Open-Label Extension Period: Change From Baseline in Disease Burden Score
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
Data for this outcome measure was not collected due to the change in planned analysis.
Posted
From the first dose of study drug in open label extension period to Week 117
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
From the first dose of study drug up to Week 52
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Secondary
Open Label Extension Period: Patient-Reported Pain
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
From the first dose of study drug in open label extension period up to Week 117
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
From the first dose of study drug up to Week 52
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Secondary
Open Label Extension Period: Patient-Reported Hunger
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
From the first dose of study drug in open label extension period up to Week 117
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Secondary
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Weeks 13, 26 and 52
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Secondary
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Weeks 65, 78 and 104
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
OG001
Secondary
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Weeks 13, 26 and 52
ID
Title
Description
OG000
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Secondary
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Weeks 65, 78 and 104
ID
Title
Description
OG000
Open-Label Extension Period: Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Time Frame
From first dose of study drug to end of follow-up period [Up to Week 169]
Description
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
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
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
0
19
3
19
18
19
EG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
0
21
6
21
21
21
EG002
Randomized Post-Treatment Follow-up: Placebo
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the OLE period went straight to the 13-week post-treatment follow-up period.
0
7
1
7
4
7
EG003
Randomized Post-Treatment Follow-up: Volanesorsen
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
0
9
1
9
5
9
EG004
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
0
12
4
12
11
12
EG005
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
0
12
4
12
8
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG0030 affected9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0021 affected7 at risk
EG003
Medical device site inflammation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG0032 affected9 at risk
EG0042 affected12 at risk
EG0051 affected12 at risk
Sinusitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0022 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Skin infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Peripheral swelling
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0021 affected7 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Xanthoma
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0013 affected21 at risk
EG0021 affected7 at risk
EG003
Cardiac pacemaker insertion
Surgical and medical procedures
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site extravasation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0004 affected19 at risk
EG0015 affected21 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0016 affected21 at risk
EG0020 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Candida infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site erythema
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG00113 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site pruritus
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG00111 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0003 affected19 at risk
EG0017 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site swelling
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0018 affected21 at risk
EG0020 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 19.1
Systematic Assessment
EG0003 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site bruising
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site reaction
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site discolouration
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site mass
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site rash
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site nodule
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site induration
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site warmth
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Chills
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site discomfort
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0005 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0014 affected21 at risk
EG0020 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Insulin resistance
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 affected19 at risk
EG0014 affected21 at risk
EG0020 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0014 affected21 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0014 affected21 at risk
EG0020 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Epulis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0005 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0015 affected21 at risk
EG0020 affected7 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Protein total increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Cardiac murmur
Investigations
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Blood glucose fluctuation
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood urine present
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Glucose urine
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Red blood cells urine
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Urine protein, quantitative
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Urine protein/creatinine ratio increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
White blood cell count increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Synovial fluid white blood cells positive
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Rheumatoid factor increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Echocardiogram abnormal
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood pressure increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood fibrinogen increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Biopsy muscle
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Bacterial test
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Albumin urine present
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0014 affected21 at risk
EG0020 affected7 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dysstasia
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Splinter
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Eye swelling
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Visual impairment
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0013 affected21 at risk
EG0020 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected21 at risk
EG0020 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Sleep-related eating disorder
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Somnambulism
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected21 at risk
EG0020 affected7 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Sinus operation
Surgical and medical procedures
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Muscular dystrophy
Congenital, familial and genetic disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Asthma prophylaxis
Surgical and medical procedures
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Microcytosis
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected21 at risk
EG0020 affected7 at risk
EG003
The Sponsor decided to terminate the study early at a time point when sufficient data had been accumulated to inform a decision on further development of volanesorsen in participants with FPL.
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Units
Counts
Participants
OG00012
OG00112
Title
Denominators
Categories
Percent Change at Month 6
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000-18.4± 54.7
OG001-60.2± 43.6
Percent Change at Month 12
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG000-93.5± 44.4
OG001
Participants
OG00019
OG00121
Title
Denominators
Categories
Change at Month 3
Title
Measurements
OG000-0.51(-1.22 to 0.20)
OG001-0.21(-1.00 to 0.58)
Change at Month 6
Title
Measurements
OG0000.06(-1.02 to 1.15)
OG0010.26(-0.98 to 1.50)
Change at Month 9
Title
Measurements
OG0000.68(-0.49 to 1.85)
OG0010.48(-0.84 to 1.80)
Change at Month 12
Title
Measurements
OG0000.48(-0.49 to 1.45)
OG0010.28(-0.78 to 1.35)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
ANCOVA
0.4108
Difference in Least Square Mean
0.30
2-Sided
95
-0.43
1.03
Superiority
OG000
OG001
Month 6
ANCOVA
0.7308
Difference in Least Square Mean
0.19
2-Sided
95
-0.95
1.34
Superiority
OG000
OG001
Month 9
ANCOVA
0.7511
Difference in Least Square Mean
-0.20
2-Sided
95
-1.45
1.06
Superiority
OG000
OG001
Month 12
ANCOVA
0.7659
Difference in Least Square Mean
-0.19
2-Sided
95
-1.52
1.13
Superiority
Units
Counts
Participants
OG00012
OG00112
Title
Denominators
Categories
Change at Month 3
ParticipantsOG0006
ParticipantsOG0018
Title
Measurements
OG0000.42± 1.54
OG0010.91± 2.18
Change at Month 6
ParticipantsOG0006
ParticipantsOG0013
Title
Measurements
OG0000.35± 1.54
OG001
Change at Month 9
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG0000.35± 1.06
OG001
Change at Month 12
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG0000.00± 0.71
OG001
Units
Counts
Participants
OG00019
OG00121
Title
Denominators
Categories
Title
Measurements
OG0005.3
OG00142.9
OG000
0
OG0010
Units
Counts
Participants
OG0000
OG0010
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Units
Counts
Participants
OG0009
OG0019
Title
Denominators
Categories
Rate Pain at its Worst Last 24 Hours
Title
Measurements
OG0001.70± 1.18
OG0013.82± 2.97
Rate Pain at its Least Last 24 Hours
Title
Measurements
OG0000.95± 1.04
OG0012.78± 2.60
Rate Pain on Average
Title
Measurements
OG0001.35± 1.22
OG0013.16± 2.72
Rate Pain Right Now
Title
Measurements
OG0001.28± 1.18
OG0013.49± 2.99
General Activity
Title
Measurements
OG0001.03± 1.45
OG0013.28± 2.90
Interfere With Mood
Title
Measurements
OG0001.27± 1.46
OG0013.23± 2.94
Walking Ability
Title
Measurements
OG0001.05± 1.50
OG0013.51± 2.83
Normal Work
Title
Measurements
OG0001.08± 1.40
OG0013.48± 2.98
Relations With Other People
Title
Measurements
OG0001.08± 1.48
OG0013.18± 3.09
Sleep
Title
Measurements
OG0001.51± 1.83
OG0013.13± 3.35
Enjoyment of Life
Title
Measurements
OG0001.23± 1.65
OG0013.33± 2.94
Units
Counts
Participants
OG00019
OG00120
Title
Denominators
Categories
How Hungry You Feel
Title
Measurements
OG00029.4± 20.7
OG00129.6± 14.4
How Satisfied You Feel
Title
Measurements
OG00056.8± 22.4
OG00157.5± 15.1
How Full You Feel
Title
Measurements
OG00062.6± 20.5
OG00156.6± 18.4
How Much You Think You Can Eat
Title
Measurements
OG00033.6± 22.1
OG00136.8± 15.4
Like to Eat Something Sweet
Title
Measurements
OG00071.0± 20.8
OG00154.8± 27.1
Like to Eat Something Salty
Title
Measurements
OG00066.9± 21.7
OG00169.0± 20.2
Like to Eat Something Savory
Title
Measurements
OG00065.2± 21.4
OG00166.8± 21.9
Like to Eat Something Fatty
Title
Measurements
OG00077.9± 18.4
OG00175.9± 22.2
Visual Appeal
Title
Measurements
OG00028.6± 20.5
OG00134.5± 21.0
Smell
Title
Measurements
OG00023.4± 16.2
OG00125.4± 15.5
Taste
Title
Measurements
OG00025.5± 18.3
OG00129.1± 14.5
Aftertaste
Title
Measurements
OG00058.9± 27.5
OG00151.0± 24.6
Palatability
Title
Measurements
OG00031.3± 20.1
OG00132.2± 15.1
OG001
Open-Label Extension: Volanesorsen/Volanesorsen
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Units
Counts
Participants
OG00012
OG00112
Title
Denominators
Categories
Vitality: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG0004.46± 6.30
OG001-0.42± 13.88
Vitality: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-2.98± 12.61
OG001
Vitality: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0002.97± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Physical Functioning: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG000-4.79± 6.77
OG001
Physical Functioning: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-3.83± 5.41
OG001
Physical Functioning: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Bodily Pain: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG000-2.42± 3.42
OG001
Bodily Pain: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-7.26± 19.39
OG001
Bodily Pain: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0006.45± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
General Health Perceptions: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG0002.38± 3.36
OG001
General Health Perceptions: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-2.86± 7.40
OG001
General Health Perceptions: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Physical Role Functioning: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG0000± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Physical Role Functioning: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-10.11± 14.29
OG001
Physical Role Functioning: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Emotional Role Functioning: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG000-1.74± 2.46
OG001
Emotional Role Functioning: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG0001.74± 2.46
OG001
Emotional Role Functioning: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0003.48± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Social Role Functioning: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG0005.02± 7.09
OG001
Social Role Functioning: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-2.15± 7.09
OG001
Social Role Functioning: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
Mental Health: Change at Week 65
ParticipantsOG0002
ParticipantsOG0017
Title
Measurements
OG000-5.23± 11.10
OG001
Mental Health: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG0006.54± 9.25
OG001
Mental Health: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0002.62± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
OG001
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156).
Units
Counts
Participants
OG00012
OG00112
Title
Denominators
Categories
Index Score: Change at Week 65
ParticipantsOG0000
ParticipantsOG0017
Title
Measurements
OG001-0.06± 0.08
Index Score: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-0.02± 0.03
OG001
Index Score: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000.00± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
EQ VAS Score: Change at Week 65
ParticipantsOG0000
ParticipantsOG0017
Title
Measurements
OG001-4± 16
EQ VAS Score: Change at Week 78
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG000-15± 22
OG001
EQ VAS Score: Change at Week 104
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0002± NAStandard deviation was not estimable since only one participant was evaluable.
OG001
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
1 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0047 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0043 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0044 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0046 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0043 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0043 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0043 affected12 at risk
EG0054 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0043 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0052 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0042 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
0 affected
9 at risk
EG0040 affected12 at risk
EG0051 affected12 at risk
0 affected
9 at risk
EG0041 affected12 at risk
EG0050 affected12 at risk
-22.1
± 47.5
-0.75
± 0.35
-0.05
± 0.64
0.30
± 0.99
-0.79
± 6.89
-3.30
± 8.20
-0.41
± 3.91
0.51
± 5.29
-2.76
± 5.25
0.75
± 6.26
0.19
± 4.27
-2.55
± 8.48
-0.58
± 4.04
0.54
± 7.25
-1.48
± 4.53
-0.64
± 4.61
0.75
± 4.70
-2.00
± 7.05
0.75
± 6.85
0.23
± 7.50
-5.42
± 5.80
1.07
± 4.02
-0.67
± 3.21
-2.79
± 7.14
-0.19
± 7.91
1.05
± 6.76
-1.75
± 6.13
-2.97
± NA
Standard deviation was not estimable since only one participant was evaluable.
-5.94
± NA
Standard deviation was not estimable since only one participant was evaluable.
-1.37
± 5.81
0.00
± NA
Standard deviation was not estimable since only one participant was evaluable.
-1.91
± NA
Standard deviation was not estimable since only one participant was evaluable.
0.40
± 7.13
-11.29
± NA
Standard deviation was not estimable since only one participant was evaluable.
-10.49
± NA
Standard deviation was not estimable since only one participant was evaluable.
-2.38
± 4.42
-4.75
± NA
Standard deviation was not estimable since only one participant was evaluable.
-4.75
± NA
Standard deviation was not estimable since only one participant was evaluable.
-0
± 6.22
-2.25
± NA
Standard deviation was not estimable since only one participant was evaluable.
-4.50
± NA
Standard deviation was not estimable since only one participant was evaluable.
-3.48
± 11.37
-10.45
± NA
Standard deviation was not estimable since only one participant was evaluable.
-10.45
± NA
Standard deviation was not estimable since only one participant was evaluable.
-2.15
± 7.58
0
± NA
Standard deviation was not estimable since only one participant was evaluable.
0
± NA
Standard deviation was not estimable since only one participant was evaluable.
-1.12
± 13.67
-15.70
± NA
Standard deviation was not estimable since only one participant was evaluable.
0
± NA
Standard deviation was not estimable since only one participant was evaluable.
-0.02
± 0.12
-0.05
± 0.07
-2
± 15
-2
± 14
-4
± 16
-0.07
± NA
Standard deviation was not estimable since only one participant was evaluable.
-0.27
± NA
Standard deviation was not estimable since only one participant was evaluable.
-6
± NA
Standard deviation was not estimable since only one participant was evaluable.
0
± NA
Standard deviation was not estimable since only one participant was evaluable.