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An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT00694109
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : December 21, 2015
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Ionis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Kastle Therapeutics, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lipid Metabolism, Inborn Errors
Hypercholesterolemia, Autosomal Dominant
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Metabolic Disorder
Congenital Abnormalities
Hypercholesterolemia
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Intervention Drug: Mipomersen Sodium
Enrollment 144
Recruitment Details The study was conducted at 33 centers in 7 countries. A total of 144 patients were enrolled in the study. 1 patient never received study drug. 2 of the enrolled patients came from a phase 2 study and its extension and consequently had very different treatment from the other treated patients, and thus were excluded from all summary tables.
Pre-assignment Details Participants who successfully completed ISIS 301012 CS5 (NCT00607373), ISIS 301012CS7 (NCT00706849), ISIS 301012CS17 (NCT00694109) or MIPO3500108 (NCT00794664) with an acceptable safety profile were eligible for study.
Arm/Group Title Mipomersen
Hide Arm/Group Description Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Period Title: Overall Study
Started 142 [1]
Treated 141
Consented 2 Years Additional Treatment 42
Completed Consented Length of Treatment 60
Completed 25
Not Completed 117
Reason Not Completed
Physician Decision             3
Adverse Event             74
Not consent of more 2 years of treatment             18
Lack of Efficacy             2
Withdrawal by Subject             13
Pregnancy             1
Enrolled but not treated             1
Other             2
Consented but no additional treatment             3
[1]
This does not include 2 patients from phase 2 trial with very different treatment experience.
Arm/Group Title Mipomersen
Hide Arm/Group Description Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Baseline Participants 141
Hide Baseline Analysis Population Description
Safety set: All enrolled participants who received at least 1 injection of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants
49.3  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants
Female
57
  40.4%
Male
84
  59.6%
1.Primary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-28.5
(-31.9 to -25.1)
week 52 (n = 111)
-27
(-31.2 to -22.8)
week 76 (n = 66)
-27.3
(-33 to -21.6)
week 104 (n = 57)
-27.9
(-33.9 to -21.8)
week 130 (n = 42)
-21.9
(-31.1 to -12.7)
week 156 (n = 30)
-21.4
(-31.2 to -11.7)
week 182 (n = 26)
-23.6
(-36.6 to -10.6)
week 208 (n = 27)
-26.3
(-36.4 to -16.2)
week 234 (n = 17)
-22.5
(-34.3 to -10.6)
24 weeks post last dose (n=117)
1.6
(-2.6 to 5.9)
2.Primary Outcome
Title Percent Change From Baseline in Apolipoprotein B (Apo B)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-28.9
(-32 to -25.8)
week 52 (n = 111)
-28.1
(-32 to -24.2)
week 76 (n = 66)
-30.3
(-34.7 to -26)
week 104 (n = 57)
-31.2
(-36.5 to -25.9)
week 130 (n = 43)
-29.1
(-35.7 to -22.5)
week 156 (n = 30)
-30.2
(-38.1 to -22.2)
week 182 (n = 26)
-31.1
(-39.9 to -22.2)
week 208 (n = 27)
-33.3
(-40.8 to -25.9)
week 234 (n = 17)
-31.4
(-38.7 to -24.1)
24 weeks post last dose (n=117)
-3.46
(-6.9 to 0)
3.Primary Outcome
Title Percent Change From Baseline in Total Cholesterol
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-21.7
(-24.4 to -18.9)
week 52 (n = 111)
-20.4
(-23.9 to -16.8)
week 76 (n = 66)
-20.1
(-24.6 to -15.5)
week 104 (n = 57)
-19.8
(-24.8 to -14.7)
week 130 (n = 43)
-14.9
(-22.1 to -7.8)
week 156 (n = 30)
-14.4
(-22.3 to -6.6)
week 182 (n = 26)
-14.3
(-25 to -3.5)
week 208 (n = 27)
-16.5
(-24.2 to -8.8)
week 234 (n = 17)
-12.5
(-21.5 to -3.4)
24 weeks post last dose (n=117)
1.94
(-1.5 to 5.4)
4.Primary Outcome
Title Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-27.2
(-30.4 to -24.1)
week 52 (n = 111)
-25.4
(-29.5 to -21.3)
week 76 (n = 66)
-25
(-30.4 to -19.7)
week 104 (n = 57)
-26.2
(-32 to -20.4)
week 130 (n = 43)
-20.7
(-29.1 to -12.3)
week 156 (n = 30)
-20
(-29.6 to -10.3)
week 182 (n = 26)
-21.7
(-34.7 to -8.7)
week 208 (n = 27)
-23.9
(-33.7 to -14.1)
week 234 (n = 17)
-19.9
(-31.5 to -8.2)
24 weeks post last dose (n=117)
2.5
(-1.8 to 6.7)
5.Secondary Outcome
Title Percent Change From Baseline in Triglycerides
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-20.1
(-33.1 to -1.2)
week 52 (n = 111)
-7.9
(-31.5 to 16.9)
week 76 (n = 66)
-10.2
(-27.7 to 13.8)
week 104 (n = 57)
-12.5
(-37.1 to 7.2)
week 130 (n = 43)
-10.9
(-36 to 10)
week 156 (n = 30)
-10.4
(-23.8 to 12.7)
week 182 (n = 26)
-12.9
(-27.4 to -1.6)
week 208 (n = 27)
-13.9
(-40 to 33)
week 234 (n = 17)
1.3
(-15.4 to 15.7)
24 weeks post last dose (n=117)
2.1
(-17.2 to 27.7)
6.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n = 130)
-20.5
(-39.3 to -3.6)
week 52 (n = 111)
-19
(-33.3 to 0)
week 76 (n = 66)
-17.9
(-33.3 to -0.5)
week 104 (n = 57)
-16.6
(-36.1 to 0)
week 130 (n = 43)
-15.8
(-31.3 to 0)
week 156 (n = 30)
-9.1
(-33.8 to 7.3)
week 182 (n = 26)
-9
(-27.2 to 7.6)
week 208 (n = 27)
-9.9
(-32.5 to 4.1)
week 234 (n = 17)
-18.3
(-31.6 to -4.8)
24 weeks post last dose (n=117)
0
(-6 to 5)
7.Secondary Outcome
Title Percent Change From Baseline in LDL Particles' Size (Total)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
-26.77
(-32.7 to -20.8)
week 104 (n = 47)
-27.77
(-35.3 to -20.3)
week 156 (n = 20)
-25.1
(-40.3 to -9.9)
week 208 (n = 19)
-32.65
(-44.9 to -20.4)
End of treatment (n=139)
-22.63
(-27 to -18.3)
24 weeks post last dose (n=115)
6.11
(0.8 to 11.5)
8.Secondary Outcome
Title Percent Change From Baseline in LDL Particles' Size (Large)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
-5.01
(-16.8 to 6.8)
week 104 (n = 47)
-14.32
(-27 to -1.6)
week 156 (n = 20)
-27.04
(-40.6 to -13.4)
week 208 (n = 19)
-22.67
(-41.6 to -3.8)
End of treatment (n=139)
-2.94
(-13.2 to 7.3)
24 weeks post last dose (n=115)
6.19
(-6.1 to 18.5)
9.Secondary Outcome
Title Percent Change From Baseline in LDL Particles' Size (Medium)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
-9.50
(-31.8 to 12.8)
week 104 (n = 47)
11.09
(-42.2 to 64.4)
week 156 (n = 20)
-19.62
(-57.3 to 18)
week 208 (n = 19)
-15.82
(-62 to 30.4)
End of treatment (n=139)
-5.65
(-30.3 to 19)
24 weeks post last dose (n=115)
46.92
(5.6 to 88.2)
10.Secondary Outcome
Title Percent Change From Baseline in LDL Particles' Size (Small)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
-8.79
(-33.7 to 16.2)
week 104 (n = 47)
1.72
(-43.9 to 47.4)
week 156 (n = 20)
-18.95
(-58.8 to 20.9)
week 208 (n = 19)
-27.95
(-67.9 to 12)
End of treatment (n=139)
-5.17
(-29.2 to 18.8)
24 weeks post last dose (n=115)
51.94
(7.7 to 96.2)
11.Secondary Outcome
Title Percent Change From Baseline in LDL Particles' Size (Very Small)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
-5.05
(-32.2 to 22.2)
week 104 (n = 47)
-0.11
(-44.4 to 44.2)
week 156 (n = 20)
-18.7
(-59.2 to 21.8)
week 208 (n = 19)
-30.77
(-69.3 to 7.8)
End of treatment (n=139)
0.75
(-28 to 29.5)
24 weeks post last dose (n=115)
60.22
(7.5 to 112.9)
12.Secondary Outcome
Title Percent Change From Baseline in HDL Particles' Size (Large)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 89)
160.8
(-38.3 to 359.9)
week 104 (n = 47)
43.23
(-12.2 to 98.7)
week 156 (n = 20)
58.26
(-38 to 154.6)
week 208 (n = 19)
61.76
(-41.6 to 165.2)
End of treatment (n=134)
121.16
(-17.3 to 259.6)
24 weeks post last dose (n=110)
85.93
(-7.3 to 179.1)
13.Secondary Outcome
Title Percent Change From Baseline in HDL Particles' Size (Medium)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 44)
154.77
(2.8 to 306.8)
week 104 (n = 28)
176.14
(-68.6 to 420.9)
week 156 (n = 9)
21.24
(-65.1 to 107.6)
week 208 (n = 8)
838.32
(-1109.3 to 2785.9)
End of treatment (n= 68)
388.16
(94.5 to 681.8)
24 weeks post last dose (n=56)
233.78
(7.9 to 459.7)
14.Secondary Outcome
Title Percent Change From Baseline in HDL Particles' Size (Small)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
1.83
(-7.3 to 10.9)
week 104 (n = 47)
-9.81
(-17.7 to -2)
week 156 (n = 20)
-14.18
(-25.1 to -3.2)
week 208 (n = 19)
-11.47
(-20 to -2.9)
End of treatment (n= 139)
0.44
(-6.9 to 7.7)
24 weeks post last dose (n=115)
8.31
(0.6 to 16)
15.Secondary Outcome
Title Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 79)
-9.9
(-45.6 to 25.8)
week 104 (n = 40)
-27.35
(-66.5 to 11.8)
week 156 (n = 16)
155.42
(-90.1 to 401)
week 208 (n = 15)
32.88
(-104 to 169.8)
End of treatment (n= 122)
24.66
(-28.4 to 77.8)
24 weeks post last dose (n=101)
57.46
(15.2 to 99.8)
16.Secondary Outcome
Title Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 86)
109.23
(33.7 to 184.8)
week 104 (n = 46)
107.5
(-10.2 to 225.2)
week 156 (n = 19)
123.42
(-113 to 359.8)
week 208 (n = 18)
241.76
(-241.5 to 725.1)
End of treatment (n= 132)
86.75
(28.4 to 145.1)
24 weeks post last dose (n=110)
90.82
(21.8 to 159.9)
17.Secondary Outcome
Title Percent Change From Baseline in VLDL Particles' Size (Medium)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 88)
70.81
(2.1 to 139.5)
week 104 (n = 47)
97.74
(-21 to 216.5)
week 156 (n = 20)
172.46
(5.3 to 339.7)
week 208 (n = 19)
98.7
(-71.3 to 268.7)
End of treatment (n= 136)
63.25
(12.1 to 114.4)
24 weeks post last dose (n=113)
99.57
(16.8 to 182.3)
18.Secondary Outcome
Title Percent Change From Baseline in VLDL Particles' Size (Small)
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
49.51
(-41.1 to 140.4)
week 104 (n = 47)
30.48
(-75.1 to 136.1)
week 156 (n = 20)
9.34
(-48.3 to 67)
week 208 (n = 19)
-30.36
(-49.8 to -10.9)
End of treatment (n= 139)
31.27
(-27.3 to 89.8)
24 weeks post last dose (n=115)
32.14
(-5.3 to 69.6)
19.Secondary Outcome
Title Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 140
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 52 (n = 91)
19.94
(-36.7 to 74.6)
week 104 (n = 47)
-14.25
(-36.4 to 7.9)
week 156 (n = 20)
3.48
(-27.5 to 34.5)
week 208 (n = 19)
-18.66
(-43.6 to 6.3)
End of treatment (n= 139)
12.82
(-25.5 to 51.2)
24 weeks post last dose (n=115)
19.69
(3.2 to 36.1)
20.Secondary Outcome
Title Change From Baseline in C-Reactive Protein
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n=130)
0.67
(-0.8 to 2.1)
week 52 (n=111)
-0.37
(-1.4 to 0.6)
week 76 (n=84)
-1.05
(-2 to -0.1)
week 104 (n=58)
0.12
(-0.8 to 1)
week 130 (n=42)
-0.18
(-1.1 to 0.8)
week 156 (n=30)
0.02
(-0.5 to 2.1)
week 182 (n=31)
0.73
(0.1 to 1.4)
week 208 (n=27)
0.2
(-0.5 to 0.9)
week 234 (n=18)
0.53
(-0.5 to 1.5)
End of treatment (n=140)
0.41
(-0.6 to 1.4)
24 weeks post last dose (n=116)
0.09
(-0.9 to 1.1)
21.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-1
Hide Description Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
Time Frame Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.
Arm/Group Title Mipomersen
Hide Arm/Group Description:
Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
Overall Number of Participants Analyzed 141
Mean (95% Confidence Interval)
Unit of Measure: percent change
week 26 (n=130)
-1.01
(-3.8 to 1.7)
week 52 (n=111)
-1.59
(-4.7 to 1.6)
week 76 (n=66)
-3.73
(-7.9 to 0.5)
week 104 (n=57)
-4.33
(-9.1 to 0.4)
week 130 (n=43)
-1.37
(-6.1 to 3.4)
week 156 (n=30)
-5.55
(-11.2 to 0)
week 182 (n=26)
-3.17
(-9.4 to 3.1)
week 208 (n=27)
-2.19
(-7.2 to 2.8)
week 234 (n=17)
3.68
(-3 to 10.3)
24 weeks post last dose (n = 117)
-0.67
(-3.5 to 2.2)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (59.7 months) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the start of study drug in this study up to 24 weeks post-treatment).
 
Arm/Group Title Mipomersen
Hide Arm/Group Description Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
All-Cause Mortality
Mipomersen
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mipomersen
Affected / at Risk (%)
Total   36/141 (25.53%) 
Blood and lymphatic system disorders   
Splenic haemorrhage  1  1/141 (0.71%) 
Cardiac disorders   
Acute coronary syndrome  1  1/141 (0.71%) 
Acute myocardial infarction  1  2/141 (1.42%) 
Angina pectoris  1  3/141 (2.13%) 
Angina unstable  1  1/141 (0.71%) 
Aortic valve stenosis  1  2/141 (1.42%) 
Atrial fibrillation  1  3/141 (2.13%) 
Cardiac failure congestive  1  1/141 (0.71%) 
Coronary artery disease  1  3/141 (2.13%) 
Myocardial infarction  1  1/141 (0.71%) 
Supraventricular tachycardia  1  1/141 (0.71%) 
Gastrointestinal disorders   
Diverticulum intestinal  1  1/141 (0.71%) 
General disorders   
Chest pain  1  1/141 (0.71%) 
Device malfunction  1  1/141 (0.71%) 
Non-cardiac chest pain  1  4/141 (2.84%) 
Pyrexia  1  1/141 (0.71%) 
Hepatobiliary disorders   
Biliary colic  1  1/141 (0.71%) 
Immune system disorders   
Contrast media allergy  1  1/141 (0.71%) 
Infections and infestations   
Appendicitis  1  1/141 (0.71%) 
Influenza  1  1/141 (0.71%) 
Injury, poisoning and procedural complications   
Ankle fracture  1  2/141 (1.42%) 
Coronary artery restenosis  1  1/141 (0.71%) 
Extradural haematoma  1  1/141 (0.71%) 
Gastrointestinal anastomotic leak  1  1/141 (0.71%) 
Metabolism and nutrition disorders   
Dehydration  1  1/141 (0.71%) 
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/141 (0.71%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/141 (0.71%) 
Breast cancer  1  1/141 (0.71%) 
Rectal cancer  1  1/141 (0.71%) 
Squamous cell carcinoma  1  1/141 (0.71%) 
Nervous system disorders   
Amnesia  1  1/141 (0.71%) 
Arachnoid cyst  1  1/141 (0.71%) 
Dementia Alzheimer's type  1  1/141 (0.71%) 
Partial seizures  1  1/141 (0.71%) 
Syncope  1  2/141 (1.42%) 
Psychiatric disorders   
Alcoholism  1  1/141 (0.71%) 
Renal and urinary disorders   
Glomerulonephritis membranous  1  1/141 (0.71%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/141 (0.71%) 
Dyspnoea  1  1/141 (0.71%) 
Pulmonary hypertension  1  1/141 (0.71%) 
Surgical and medical procedures   
Ileostomy  1  1/141 (0.71%) 
Vascular disorders   
Aortic aneurysm  1  1/141 (0.71%) 
Aortic stenosis  1  1/141 (0.71%) 
Femoral artery occlusion  1  1/141 (0.71%) 
Peripheral artery dissection  1  1/141 (0.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mipomersen
Affected / at Risk (%)
Total   141/141 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  9/141 (6.38%) 
Leukopenia  1  1/141 (0.71%) 
Lymphadenopathy  1  3/141 (2.13%) 
Thrombocytopenia  1  5/141 (3.55%) 
Cardiac disorders   
Angina pectoris  1  14/141 (9.93%) 
Aortic valve disease  1  1/141 (0.71%) 
Aortic valve incompetence  1  1/141 (0.71%) 
Atrial fibrillation  1  4/141 (2.84%) 
Atrioventricular block second degree  1  1/141 (0.71%) 
Bradycardia  1  1/141 (0.71%) 
Coronary artery disease  1  2/141 (1.42%) 
Extrasystoles  1  1/141 (0.71%) 
Myocardial ischaemia  1  1/141 (0.71%) 
Palpitations  1  4/141 (2.84%) 
Supraventricular extrasystoles  1  2/141 (1.42%) 
Tachycardia  1  3/141 (2.13%) 
Ventricular dysfunction  1  1/141 (0.71%) 
Ventricular extrasystoles  1  2/141 (1.42%) 
Ear and labyrinth disorders   
Ear discomfort  1  1/141 (0.71%) 
Ear pain  1  2/141 (1.42%) 
Eustachian tube dysfunction  1  1/141 (0.71%) 
Hypoacusis  1  1/141 (0.71%) 
Tinnitus  1  2/141 (1.42%) 
Vertigo  1  3/141 (2.13%) 
Endocrine disorders   
Hypothyroidism  1  1/141 (0.71%) 
Eye disorders   
Arcus lipoides  1  2/141 (1.42%) 
Cataract  1  4/141 (2.84%) 
Diplopia  1  1/141 (0.71%) 
Dry eye  1  2/141 (1.42%) 
Eye irritation  1  1/141 (0.71%) 
Eye pain  1  1/141 (0.71%) 
Eye swelling  1  1/141 (0.71%) 
Eyelid cyst  1  1/141 (0.71%) 
Halo vision  1  1/141 (0.71%) 
Ocular hyperaemia  1  1/141 (0.71%) 
Presbyopia  1  1/141 (0.71%) 
Vision blurred  1  3/141 (2.13%) 
Vitreous floaters  1  1/141 (0.71%) 
Gastrointestinal disorders   
Abdominal discomfort  1  2/141 (1.42%) 
Abdominal distension  1  3/141 (2.13%) 
Abdominal hernia  1  1/141 (0.71%) 
Abdominal pain  1  14/141 (9.93%) 
Abdominal pain lower  1  5/141 (3.55%) 
Abdominal pain upper  1  7/141 (4.96%) 
Anal haemorrhage  1  1/141 (0.71%) 
Bezoar  1  1/141 (0.71%) 
Colitis  1  1/141 (0.71%) 
Constipation  1  6/141 (4.26%) 
Dental caries  1  2/141 (1.42%) 
Diarrhoea  1  21/141 (14.89%) 
Diverticulum  1  1/141 (0.71%) 
Diverticulum intestinal  1  2/141 (1.42%) 
Dyspepsia  1  5/141 (3.55%) 
Dysphagia  1  2/141 (1.42%) 
Faecal incontinence  1  1/141 (0.71%) 
Faeces soft  1  1/141 (0.71%) 
Flatulence  1  1/141 (0.71%) 
Food poisoning  1  3/141 (2.13%) 
Gastric ulcer  1  2/141 (1.42%) 
Gastritis  1  4/141 (2.84%) 
Gastritis erosive  1  1/141 (0.71%) 
Gastrooesophageal reflux disease  1  4/141 (2.84%) 
Gingival recession  1  1/141 (0.71%) 
Haematochezia  1  1/141 (0.71%) 
Haemorrhoids  1  2/141 (1.42%) 
Hiatus hernia  1  3/141 (2.13%) 
Hypoaesthesia oral  1  1/141 (0.71%) 
Inguinal hernia  1  1/141 (0.71%) 
Intestinal obstruction  1  1/141 (0.71%) 
Lip blister  1  1/141 (0.71%) 
Lip swelling  1  2/141 (1.42%) 
Mouth ulceration  1  1/141 (0.71%) 
Nausea  1  37/141 (26.24%) 
Odynophagia  1  1/141 (0.71%) 
Oesophageal dilatation  1  1/141 (0.71%) 
Oesophageal spasm  1  1/141 (0.71%) 
Oesophagitis  1  1/141 (0.71%) 
Pancreatic duct dilatation  1  1/141 (0.71%) 
Periodontal disease  1  1/141 (0.71%) 
Proctitis ulcerative  1  1/141 (0.71%) 
Rectal haemorrhage  1  1/141 (0.71%) 
Retching  1  1/141 (0.71%) 
Tooth impacted  1  1/141 (0.71%) 
Toothache  1  5/141 (3.55%) 
Umbilical hernia  1  1/141 (0.71%) 
Vomiting  1  13/141 (9.22%) 
Vomiting projectile  1  1/141 (0.71%) 
General disorders   
Asthenia  1  6/141 (4.26%) 
Chest discomfort  1  2/141 (1.42%) 
Chest pain  1  9/141 (6.38%) 
Chills  1  27/141 (19.15%) 
Cyst  1  2/141 (1.42%) 
Device breakage  1  1/141 (0.71%) 
Device failure  1  1/141 (0.71%) 
Discomfort  1  1/141 (0.71%) 
Exercise tolerance decreased  1  1/141 (0.71%) 
Facial pain  1  1/141 (0.71%) 
Fatigue  1  38/141 (26.95%) 
Feeling cold  1  3/141 (2.13%) 
Gait disturbance  1  2/141 (1.42%) 
Influenza like illness  1  70/141 (49.65%) 
Injection site atrophy  1  1/141 (0.71%) 
Injection site bruising  1  72/141 (51.06%) 
Injection site discolouration  1  55/141 (39.01%) 
Injection site discomfort  1  14/141 (9.93%) 
Injection site eczema  1  1/141 (0.71%) 
Injection site erythema  1  117/141 (82.98%) 
Injection site exfoliation  1  1/141 (0.71%) 
Injection site extravasation  1  1/141 (0.71%) 
Injection site haematoma  1  2/141 (1.42%) 
Injection site haemorrhage  1  17/141 (12.06%) 
Injection site hypersensitivity  1  2/141 (1.42%) 
Injection site hypertrophy  1  3/141 (2.13%) 
Injection site hypoaesthesia  1  2/141 (1.42%) 
Injection site induration  1  31/141 (21.99%) 
Injection site inflammation  1  12/141 (8.51%) 
Injection site lymphadenopathy  1  1/141 (0.71%) 
Injection site macule  1  4/141 (2.84%) 
Injection site mass  1  14/141 (9.93%) 
Injection site nodule  1  9/141 (6.38%) 
Injection site oedema  1  19/141 (13.48%) 
Injection site pain  1  102/141 (72.34%) 
Injection site pallor  1  3/141 (2.13%) 
Injection site papule  1  7/141 (4.96%) 
Injection site paraesthesia  1  3/141 (2.13%) 
Injection site pruritus  1  46/141 (32.62%) 
Injection site rash  1  16/141 (11.35%) 
Injection site reaction  1  12/141 (8.51%) 
Injection site recall reaction  1  10/141 (7.09%) 
Injection site swelling  1  31/141 (21.99%) 
Injection site urticaria  1  10/141 (7.09%) 
Injection site vesicles  1  3/141 (2.13%) 
Injection site warmth  1  19/141 (13.48%) 
Local swelling  1  2/141 (1.42%) 
Localised oedema  1  2/141 (1.42%) 
Malaise  1  3/141 (2.13%) 
Non-cardiac chest pain  1  5/141 (3.55%) 
Oedema peripheral  1  10/141 (7.09%) 
Pain  1  13/141 (9.22%) 
Pyrexia  1  25/141 (17.73%) 
Swelling  1  1/141 (0.71%) 
Temperature intolerance  1  1/141 (0.71%) 
Tenderness  1  1/141 (0.71%) 
Vaccination site pain  1  1/141 (0.71%) 
Vessel puncture site bruise  1  1/141 (0.71%) 
Xerosis  1  2/141 (1.42%) 
Hepatobiliary disorders   
Biliary cyst  1  1/141 (0.71%) 
Cholecystitis acute  1  1/141 (0.71%) 
Cholecystitis chronic  1  1/141 (0.71%) 
Cholelithiasis  1  1/141 (0.71%) 
Hepatic cyst  1  1/141 (0.71%) 
Hepatic fibrosis  1  1/141 (0.71%) 
Hepatic steatosis  1  17/141 (12.06%) 
Hepatomegaly  1  9/141 (6.38%) 
Immune system disorders   
Hypersensitivity  1  1/141 (0.71%) 
Seasonal allergy  1  3/141 (2.13%) 
Serum sickness  1  1/141 (0.71%) 
Infections and infestations   
Abscess limb  1  1/141 (0.71%) 
Acarodermatitis  1  1/141 (0.71%) 
Acute sinusitis  1  2/141 (1.42%) 
Anal abscess  1  1/141 (0.71%) 
Asymptomatic bacteriuria  1  1/141 (0.71%) 
Bronchitis  1  10/141 (7.09%) 
Bronchopneumonia  1  1/141 (0.71%) 
Cellulitis  1  2/141 (1.42%) 
Conjunctivitis  1  1/141 (0.71%) 
Cystitis  1  1/141 (0.71%) 
Diverticulitis  1  1/141 (0.71%) 
Ear infection  1  4/141 (2.84%) 
Eye infection  1  2/141 (1.42%) 
Folliculitis  1  1/141 (0.71%) 
Furuncle  1  1/141 (0.71%) 
Gastroenteritis  1  4/141 (2.84%) 
Gastroenteritis viral  1  5/141 (3.55%) 
Gastrointestinal infection  1  1/141 (0.71%) 
Gastrointestinal viral infection  1  5/141 (3.55%) 
Genital herpes simplex  1  1/141 (0.71%) 
Giardiasis  1  1/141 (0.71%) 
H1N1 influenza  1  1/141 (0.71%) 
Helicobacter gastritis  1  1/141 (0.71%) 
Herpes zoster  1  4/141 (2.84%) 
Influenza  1  17/141 (12.06%) 
Kidney infection  1  2/141 (1.42%) 
Laryngitis  1  1/141 (0.71%) 
Localised infection  1  1/141 (0.71%) 
Lower respiratory tract infection  1  3/141 (2.13%) 
Nasopharyngitis  1  28/141 (19.86%) 
Onychomycosis  1  1/141 (0.71%) 
Oral herpes  1  1/141 (0.71%) 
Otitis externa  1  2/141 (1.42%) 
Otitis media acute  1  1/141 (0.71%) 
Paronychia  1  1/141 (0.71%) 
Pharyngitis  1  4/141 (2.84%) 
Pharyngitis streptococcal  1  2/141 (1.42%) 
Pneumonia  1  2/141 (1.42%) 
Post procedural infection  1  1/141 (0.71%) 
Respiratory tract infection  1  2/141 (1.42%) 
Rhinitis  1  4/141 (2.84%) 
Sinobronchitis  1  1/141 (0.71%) 
Sinusitis  1  20/141 (14.18%) 
Skin bacterial infection  1  1/141 (0.71%) 
Tinea cruris  1  1/141 (0.71%) 
Tinea versicolour  1  1/141 (0.71%) 
Tooth abscess  1  2/141 (1.42%) 
Tooth infection  1  2/141 (1.42%) 
Upper respiratory tract infection  1  27/141 (19.15%) 
Urinary tract infection  1  23/141 (16.31%) 
Vaginal infection  1  1/141 (0.71%) 
Viral infection  1  2/141 (1.42%) 
Viral upper respiratory tract infection  1  2/141 (1.42%) 
Wound infection  1  1/141 (0.71%) 
Wound sepsis  1  2/141 (1.42%) 
Injury, poisoning and procedural complications   
Animal scratch  1  1/141 (0.71%) 
Ankle fracture  1  1/141 (0.71%) 
Arthropod bite  1  4/141 (2.84%) 
Arthropod sting  1  1/141 (0.71%) 
Back injury  1  1/141 (0.71%) 
Brain contusion  1  1/141 (0.71%) 
Concussion  1  1/141 (0.71%) 
Contusion  1  9/141 (6.38%) 
Epicondylitis  1  3/141 (2.13%) 
Excoriation  1  2/141 (1.42%) 
Fall  1  2/141 (1.42%) 
Fractured coccyx  1  1/141 (0.71%) 
Gastrointestinal anastomotic leak  1  1/141 (0.71%) 
Incisional hernia  1  1/141 (0.71%) 
Injury  1  3/141 (2.13%) 
Jaw fracture  1  1/141 (0.71%) 
Kidney contusion  1  1/141 (0.71%) 
Laceration  1  7/141 (4.96%) 
Ligament sprain  1  8/141 (5.67%) 
Limb injury  1  2/141 (1.42%) 
Meniscus injury  1  1/141 (0.71%) 
Muscle strain  1  3/141 (2.13%) 
Post procedural contusion  1  1/141 (0.71%) 
Post-traumatic pain  1  3/141 (2.13%) 
Procedural pain  1  9/141 (6.38%) 
Procedural vomiting  1  1/141 (0.71%) 
Radius fracture  1  1/141 (0.71%) 
Repetitive strain injury  1  1/141 (0.71%) 
Road traffic accident  1  2/141 (1.42%) 
Scratch  1  1/141 (0.71%) 
Spinal compression fracture  1  1/141 (0.71%) 
Splenic haematoma  1  1/141 (0.71%) 
Sunburn  1  1/141 (0.71%) 
Suture related complication  1  1/141 (0.71%) 
Thermal burn  1  5/141 (3.55%) 
Tibia fracture  1  1/141 (0.71%) 
Tooth fracture  1  3/141 (2.13%) 
Vaccination complication  1  1/141 (0.71%) 
Wound  1  2/141 (1.42%) 
Investigations   
Alanine aminotransferase increased  1  26/141 (18.44%) 
Albumin urine present  1  1/141 (0.71%) 
Aspartate aminotransferase increased  1  21/141 (14.89%) 
Beta 2 microglobulin urine increased  1  2/141 (1.42%) 
Blood alkaline phosphatase increased  1  2/141 (1.42%) 
Blood bicarbonate decreased  1  1/141 (0.71%) 
Blood creatine phosphokinase increased  1  2/141 (1.42%) 
Blood creatinine increased  1  5/141 (3.55%) 
Blood phosphorus decreased  1  1/141 (0.71%) 
Blood potassium increased  1  2/141 (1.42%) 
Blood pressure increased  1  1/141 (0.71%) 
Blood testosterone decreased  1  1/141 (0.71%) 
Blood uric acid increased  1  2/141 (1.42%) 
Body temperature increased  1  2/141 (1.42%) 
C-reactive protein increased  1  1/141 (0.71%) 
Cardiac murmur  1  3/141 (2.13%) 
Carotid bruit  1  4/141 (2.84%) 
Electrocardiogram ST segment depression  1  1/141 (0.71%) 
Electrocardiogram T wave abnormal  1  1/141 (0.71%) 
Electrocardiogram T wave inversion  1  2/141 (1.42%) 
Electrocardiogram abnormal  1  1/141 (0.71%) 
Gamma-glutamyltransferase increased  1  1/141 (0.71%) 
Haematocrit decreased  1  2/141 (1.42%) 
Haemoglobin decreased  1  2/141 (1.42%) 
Heart rate increased  1  1/141 (0.71%) 
Hepatic enzyme increased  1  6/141 (4.26%) 
International normalised ratio increased  1  2/141 (1.42%) 
Liver function test abnormal  1  3/141 (2.13%) 
Liver scan abnormal  1  1/141 (0.71%) 
Lymph node palpable  1  1/141 (0.71%) 
Lymphocyte count decreased  1  1/141 (0.71%) 
Multiple gated acquisition scan abnormal  1  1/141 (0.71%) 
Mycobacterium tuberculosis complex test positive  1  1/141 (0.71%) 
Nuclear magnetic resonance imaging abnormal  1  1/141 (0.71%) 
Peripheral pulse decreased  1  1/141 (0.71%) 
Platelet count decreased  1  5/141 (3.55%) 
Protein urine present  1  1/141 (0.71%) 
Prothrombin time prolonged  1  1/141 (0.71%) 
Red blood cell acanthocytes present  1  1/141 (0.71%) 
Red blood cell count decreased  1  1/141 (0.71%) 
Red blood cell schistocytes present  1  1/141 (0.71%) 
Red blood cells urine positive  1  2/141 (1.42%) 
Scan myocardial perfusion abnormal  1  2/141 (1.42%) 
Transaminases increased  1  1/141 (0.71%) 
Urine analysis abnormal  1  1/141 (0.71%) 
Weight decreased  1  1/141 (0.71%) 
Weight increased  1  1/141 (0.71%) 
White blood cell count decreased  1  1/141 (0.71%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/141 (2.13%) 
Dehydration  1  2/141 (1.42%) 
Fluid retention  1  1/141 (0.71%) 
Glucose tolerance impaired  1  2/141 (1.42%) 
Gout  1  1/141 (0.71%) 
Hyperkalaemia  1  1/141 (0.71%) 
Hypocalcaemia  1  1/141 (0.71%) 
Iron deficiency  1  2/141 (1.42%) 
Type 2 diabetes mellitus  1  1/141 (0.71%) 
Vitamin B12 deficiency  1  1/141 (0.71%) 
Vitamin D deficiency  1  1/141 (0.71%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  19/141 (13.48%) 
Arthritis  1  4/141 (2.84%) 
Back pain  1  24/141 (17.02%) 
Bone pain  1  1/141 (0.71%) 
Bunion  1  1/141 (0.71%) 
Bursitis  1  2/141 (1.42%) 
Cervical spinal stenosis  1  1/141 (0.71%) 
Chondrocalcinosis pyrophosphate  1  1/141 (0.71%) 
Coccydynia  1  1/141 (0.71%) 
Costochondritis  1  1/141 (0.71%) 
Dupuytren's contracture  1  2/141 (1.42%) 
Exostosis  1  1/141 (0.71%) 
Fibromyalgia  1  1/141 (0.71%) 
Flank pain  1  2/141 (1.42%) 
Fracture pain  1  1/141 (0.71%) 
Haemarthrosis  1  1/141 (0.71%) 
Intervertebral disc degeneration  1  1/141 (0.71%) 
Joint effusion  1  1/141 (0.71%) 
Joint swelling  1  1/141 (0.71%) 
Muscle atrophy  1  1/141 (0.71%) 
Muscle spasms  1  8/141 (5.67%) 
Muscle tightness  1  1/141 (0.71%) 
Muscle twitching  1  1/141 (0.71%) 
Muscular weakness  1  4/141 (2.84%) 
Musculoskeletal chest pain  1  3/141 (2.13%) 
Musculoskeletal discomfort  1  1/141 (0.71%) 
Musculoskeletal pain  1  7/141 (4.96%) 
Musculoskeletal stiffness  1  5/141 (3.55%) 
Myalgia  1  33/141 (23.40%) 
Neck pain  1  6/141 (4.26%) 
Osteoarthritis  1  4/141 (2.84%) 
Osteopenia  1  1/141 (0.71%) 
Pain in extremity  1  14/141 (9.93%) 
Pain in jaw  1  1/141 (0.71%) 
Plantar fasciitis  1  1/141 (0.71%) 
Rotator cuff syndrome  1  3/141 (2.13%) 
Soft tissue atrophy  1  1/141 (0.71%) 
Spinal osteoarthritis  1  5/141 (3.55%) 
Temporomandibular joint syndrome  1  1/141 (0.71%) 
Tendon pain  1  1/141 (0.71%) 
Tendonitis  1  2/141 (1.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  4/141 (2.84%) 
Benign breast neoplasm  1  1/141 (0.71%) 
Lipoma  1  1/141 (0.71%) 
Melanocytic naevus  1  1/141 (0.71%) 
Seborrhoeic keratosis  1  3/141 (2.13%) 
Skin papilloma  1  1/141 (0.71%) 
Thyroid neoplasm  1  1/141 (0.71%) 
Nervous system disorders   
Burning sensation  1  2/141 (1.42%) 
Carotid artery stenosis  1  1/141 (0.71%) 
Carpal tunnel syndrome  1  2/141 (1.42%) 
Cluster headache  1  1/141 (0.71%) 
Cognitive disorder  1  1/141 (0.71%) 
Dizziness  1  10/141 (7.09%) 
Dizziness postural  1  2/141 (1.42%) 
Dysgeusia  1  1/141 (0.71%) 
Headache  1  35/141 (24.82%) 
Hypoaesthesia  1  7/141 (4.96%) 
Lethargy  1  2/141 (1.42%) 
Loss of consciousness  1  1/141 (0.71%) 
Migraine  1  2/141 (1.42%) 
Migraine with aura  1  1/141 (0.71%) 
Morton's neuralgia  1  1/141 (0.71%) 
Nerve compression  1  1/141 (0.71%) 
Neuralgia  1  1/141 (0.71%) 
Neuropathy peripheral  1  1/141 (0.71%) 
Orthostatic intolerance  1  1/141 (0.71%) 
Paraesthesia  1  4/141 (2.84%) 
Post herpetic neuralgia  1  1/141 (0.71%) 
Presyncope  1  2/141 (1.42%) 
Restless legs syndrome  1  1/141 (0.71%) 
Sciatica  1  3/141 (2.13%) 
Sinus headache  1  4/141 (2.84%) 
Somnolence  1  1/141 (0.71%) 
Syncope  1  4/141 (2.84%) 
Transient ischaemic attack  1  1/141 (0.71%) 
Tremor  1  8/141 (5.67%) 
VIIth nerve paralysis  1  1/141 (0.71%) 
Psychiatric disorders   
Abnormal sleep-related event  1  1/141 (0.71%) 
Anxiety  1  6/141 (4.26%) 
Attention deficit/hyperactivity disorder  1  1/141 (0.71%) 
Confusional state  1  1/141 (0.71%) 
Depression  1  8/141 (5.67%) 
Insomnia  1  9/141 (6.38%) 
Libido decreased  1  2/141 (1.42%) 
Panic attack  1  1/141 (0.71%) 
Stress  1  2/141 (1.42%) 
Renal and urinary disorders   
Albuminuria  1  1/141 (0.71%) 
Bladder discomfort  1  1/141 (0.71%) 
Dysuria  1  4/141 (2.84%) 
Haematuria  1  6/141 (4.26%) 
Micturition urgency  1  1/141 (0.71%) 
Nephrolithiasis  1  2/141 (1.42%) 
Nephropathy  1  1/141 (0.71%) 
Pollakiuria  1  4/141 (2.84%) 
Proteinuria  1  6/141 (4.26%) 
Pyelocaliectasis  1  1/141 (0.71%) 
Pyuria  1  1/141 (0.71%) 
Renal cyst  1  4/141 (2.84%) 
Renal failure  1  1/141 (0.71%) 
Stress urinary incontinence  1  1/141 (0.71%) 
Urge incontinence  1  1/141 (0.71%) 
Urinary tract disorder  1  1/141 (0.71%) 
Reproductive system and breast disorders   
Amenorrhoea  1  1/141 (0.71%) 
Breast mass  1  2/141 (1.42%) 
Dyspareunia  1  1/141 (0.71%) 
Erectile dysfunction  1  1/141 (0.71%) 
Menopausal symptoms  1  1/141 (0.71%) 
Menorrhagia  1  1/141 (0.71%) 
Menstruation delayed  1  1/141 (0.71%) 
Ovarian cyst  1  1/141 (0.71%) 
Pelvic pain  1  1/141 (0.71%) 
Prostatitis  1  1/141 (0.71%) 
Pruritus genital  1  1/141 (0.71%) 
Testicular cyst  1  1/141 (0.71%) 
Uterine haemorrhage  1  1/141 (0.71%) 
Uterine prolapse  1  1/141 (0.71%) 
Vaginal discharge  1  1/141 (0.71%) 
Vaginal haemorrhage  1  2/141 (1.42%) 
Vulvovaginal burning sensation  1  1/141 (0.71%) 
Vulvovaginal dryness  1  1/141 (0.71%) 
Respiratory, thoracic and mediastinal disorders   
Bronchial hyperreactivity  1  1/141 (0.71%) 
Cough  1  15/141 (10.64%) 
Dysphonia  1  1/141 (0.71%) 
Dyspnoea  1  12/141 (8.51%) 
Dyspnoea exertional  1  4/141 (2.84%) 
Epistaxis  1  4/141 (2.84%) 
Hiccups  1  1/141 (0.71%) 
Hypoxia  1  1/141 (0.71%) 
Nasal congestion  1  3/141 (2.13%) 
Oropharyngeal pain  1  13/141 (9.22%) 
Painful respiration  1  1/141 (0.71%) 
Paranasal sinus hypersecretion  1  1/141 (0.71%) 
Pneumonia aspiration  1  1/141 (0.71%) 
Productive cough  1  2/141 (1.42%) 
Respiratory tract congestion  1  2/141 (1.42%) 
Rhinitis allergic  1  2/141 (1.42%) 
Rhinorrhoea  1  8/141 (5.67%) 
Sinus congestion  1  6/141 (4.26%) 
Sinus disorder  1  1/141 (0.71%) 
Sleep apnoea syndrome  1  2/141 (1.42%) 
Upper respiratory tract congestion  1  4/141 (2.84%) 
Wheezing  1  2/141 (1.42%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  2/141 (1.42%) 
Blister  1  1/141 (0.71%) 
Cold sweat  1  1/141 (0.71%) 
Dermatitis  1  2/141 (1.42%) 
Dermatitis acneiform  1  1/141 (0.71%) 
Dermatitis allergic  1  1/141 (0.71%) 
Dermatitis contact  1  2/141 (1.42%) 
Dry skin  1  1/141 (0.71%) 
Ecchymosis  1  3/141 (2.13%) 
Eczema  1  1/141 (0.71%) 
Erythema  1  1/141 (0.71%) 
Hair growth abnormal  1  3/141 (2.13%) 
Ingrowing nail  1  1/141 (0.71%) 
Ingrown hair  1  1/141 (0.71%) 
Intertrigo  1  1/141 (0.71%) 
Lipodystrophy acquired  1  1/141 (0.71%) 
Macule  1  2/141 (1.42%) 
Onychoclasis  1  1/141 (0.71%) 
Pain of skin  1  1/141 (0.71%) 
Petechiae  1  1/141 (0.71%) 
Pigmentation disorder  1  1/141 (0.71%) 
Pruritus  1  6/141 (4.26%) 
Pruritus generalised  1  2/141 (1.42%) 
Rash  1  6/141 (4.26%) 
Rash erythematous  1  1/141 (0.71%) 
Rash maculo-papular  1  1/141 (0.71%) 
Rash papular  1  1/141 (0.71%) 
Rash pruritic  1  1/141 (0.71%) 
Rash vesicular  1  1/141 (0.71%) 
Scab  1  1/141 (0.71%) 
Skin hyperpigmentation  1  1/141 (0.71%) 
Skin lesion  1  2/141 (1.42%) 
Skin plaque  1  2/141 (1.42%) 
Urticaria  1  6/141 (4.26%) 
Xanthelasma  1  2/141 (1.42%) 
Xanthoma  1  1/141 (0.71%) 
Vascular disorders   
Aortic aneurysm  1  3/141 (2.13%) 
Aortic arteriosclerosis  1  1/141 (0.71%) 
Aortic calcification  1  1/141 (0.71%) 
Aortic dilatation  1  3/141 (2.13%) 
Aortic stenosis  1  1/141 (0.71%) 
Flushing  1  3/141 (2.13%) 
Haematoma  1  2/141 (1.42%) 
Hot flush  1  4/141 (2.84%) 
Hypertension  1  8/141 (5.67%) 
Hypertensive crisis  1  1/141 (0.71%) 
Hypotension  1  2/141 (1.42%) 
Infarction  1  1/141 (0.71%) 
Intermittent claudication  1  1/141 (0.71%) 
Orthostatic hypotension  1  1/141 (0.71%) 
Pallor  1  1/141 (0.71%) 
Peripheral coldness  1  1/141 (0.71%) 
Peripheral vascular disorder  1  1/141 (0.71%) 
Phlebitis  1  1/141 (0.71%) 
Subclavian artery stenosis  1  1/141 (0.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Kastle Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT00694109     History of Changes
Other Study ID Numbers: 301012-CS6
2005-003450-10 ( EudraCT Number )
First Submitted: June 5, 2008
First Posted: June 10, 2008
Results First Submitted: September 11, 2015
Results First Posted: December 21, 2015
Last Update Posted: September 9, 2016