Trial Outcomes & Findings for Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration (NCT NCT00362180)
NCT ID: NCT00362180
Last Updated: 2016-10-21
Results Overview
Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline, Day 26, Day 99
Results posted on
2016-10-21
Participant Flow
Participant milestones
| Measure |
Cohort A: Mipomersen
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort A: Placebo
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort D: Mipomersen
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D: Placebo
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort E: Placebo
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
|
Cohort G: Mipomersen
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Placebo Followed by Mipomersen
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Treated Period
STARTED
|
4
|
2
|
1
|
0
|
11
|
10
|
6
|
3
|
1
|
|
Treated Period
COMPLETED
|
3
|
2
|
1
|
0
|
11
|
9
|
6
|
2
|
1
|
|
Treated Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
20 Week Safety Follow-up
STARTED
|
3
|
2
|
1
|
0
|
11
|
9
|
0
|
3
|
1
|
|
20 Week Safety Follow-up
COMPLETED
|
3
|
2
|
1
|
0
|
11
|
9
|
0
|
3
|
1
|
|
20 Week Safety Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Mipomersen
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort A: Placebo
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort D: Mipomersen
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D: Placebo
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort E: Placebo
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
|
Cohort G: Mipomersen
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Placebo Followed by Mipomersen
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|---|
|
Treated Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treated Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
Baseline characteristics by cohort
| Measure |
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort D: Mipomersen
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D: Placebo
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=5 Participants
|
40.5 years
n=7 Participants
|
59.0 years
n=5 Participants
|
—
|
46.0 years
n=21 Participants
|
50.0 years
n=8 Participants
|
49.5 years
n=8 Participants
|
62.0 years
n=24 Participants
|
58.0 years
n=42 Participants
|
53.5 years
n=42 Participants
|
|
Gender
Female
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
8 participants
n=21 Participants
|
4 participants
n=8 Participants
|
1 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
20 participants
n=42 Participants
|
|
Gender
Male
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
3 participants
n=21 Participants
|
6 participants
n=8 Participants
|
5 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
18 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
11 participants
n=21 Participants
|
10 participants
n=8 Participants
|
6 participants
n=8 Participants
|
3 participants
n=24 Participants
|
1 participants
n=42 Participants
|
37 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 26, Day 99Population: Full analysis set. In Cohort E: Placebo, Day 99 N=11 instead of 10 because participant did not have a post treatment MRS by Day 26.
Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)
Baseline (Cohort E: Placebo n=11)
|
0.2 percentage of total liver content
Interval 0.1 to 0.3
|
1.2 percentage of total liver content
Interval 0.5 to 1.8
|
6.4 percentage of total liver content
Interval 6.4 to 6.4
|
0.8 percentage of total liver content
Interval 0.2 to 3.2
|
1.1 percentage of total liver content
Interval 0.3 to 3.8
|
21.4 percentage of total liver content
Interval 13.2 to 30.1
|
2.6 percentage of total liver content
Interval 2.6 to 2.6
|
2.5 percentage of total liver content
Interval 1.7 to 3.2
|
|
Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)
Day 26 (Cohort E: Placebo n=10)
|
0.3 percentage of total liver content
Interval 0.0 to 0.6
|
0.3 percentage of total liver content
Interval 0.0 to 0.5
|
4.45 percentage of total liver content
Interval 4.45 to 4.45
|
0.1 percentage of total liver content
Interval -0.4 to 0.8
|
0.1 percentage of total liver content
Interval -2.5 to 0.5
|
-1.2 percentage of total liver content
Interval -2.6 to 4.3
|
NA percentage of total liver content
Liver TG not collected at day 26 as per protocol
|
NA percentage of total liver content
Liver TG not collected at day 26 as per protocol
|
|
Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)
Day 99 (Cohort E: Placebo n=11)
|
NA percentage of total liver content
Liver TG not collected at day 99 as per protocol
|
NA percentage of total liver content
Liver TG not collected at day 99 as per protocol
|
NA percentage of total liver content
Only 1 patient was enrolled in cohort D, there was no day 99 visit for cohort D
|
-0.0 percentage of total liver content
Interval -1.5 to 1.3
|
0.4 percentage of total liver content
Interval -1.7 to 5.1
|
0.8 percentage of total liver content
Interval -2.0 to 4.3
|
-1.0 percentage of total liver content
Interval -1.0 to -1.0
|
7.8 percentage of total liver content
Interval 1.1 to 14.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set
Samples were taken following an overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline Apolipoprotein B
|
86 mg/wk
Interval 70.0 to 102.0
|
100.5 mg/wk
Interval 76.5 to 102.0
|
155 mg/wk
Interval 155.0 to 155.0
|
122.0 mg/wk
Interval 106.0 to 148.0
|
126.5 mg/wk
Interval 109.0 to 153.0
|
31.5 mg/wk
Interval 28.0 to 41.0
|
120.0 mg/wk
Interval 120.0 to 120.0
|
113.0 mg/wk
Interval 90.0 to 132.0
|
SECONDARY outcome
Timeframe: Day 26 and Day 99Population: Full analysis set with last observation carried forward.
Samples were taken following an overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in Apolipoprotein B From Baseline to Day 99
Day 26
|
-3.3 percent change
Interval -8.6 to 2.0
|
-20.8 percent change
Interval -24.8 to -13.6
|
-41.6149 percent change
Interval -41.6149 to -41.6149
|
-1.1 percent change
Interval -1.8 to 0.0
|
-1.8 percent change
Interval -16.3 to 13.4
|
3.6 percent change
Interval -4.9 to 14.3
|
NA percent change
Apolipoprotein B was not collected at day 26 as per protocol
|
NA percent change
Apolipoprotein B was not collected at day 26 as per protocol
|
|
Percent Change in Apolipoprotein B From Baseline to Day 99
Day 99
|
NA percent change
Apolipoprotein B was not collected at day 99 as per protocol
|
NA percent change
Apolipoprotein B was not collected at day 99 as per protocol
|
NA percent change
Only 1 patient was enrolled in cohort D, there was no day 99 visit for cohort D
|
6.0 percent change
Interval -2.7 to 15.3
|
-16.3 percent change
Interval -29.3 to -5.6
|
4.1 percent change
Interval 0.0 to 5.9
|
-25.8 percent change
Interval -25.8 to -25.8
|
-44.2 percent change
Interval -55.6 to -18.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set
Samples were taken following overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline Low-Density Lipoprotein Cholesterol
|
103.5 mg/wk
Interval 77.0 to 130.0
|
126.0 mg/wk
Interval 93.0 to 139.5
|
156.0 mg/wk
Interval 156.0 to 156.0
|
148.0 mg/wk
Interval 131.0 to 182.0
|
151.5 mg/wk
Interval 127.0 to 161.0
|
41.5 mg/wk
Interval 37.0 to 55.0
|
147.0 mg/wk
Interval 147.0 to 147.0
|
121.0 mg/wk
Interval 94.0 to 131.0
|
SECONDARY outcome
Timeframe: Day 26 and Day 99Population: Full analysis set with last observation carried forward.
Samples were taken following an overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99
Day 26
|
1.1 percent change
Interval -11.7 to 13.8
|
-14.3 percent change
Interval -20.5 to -6.0
|
-41.7143 percent change
Interval -41.7143 to -41.7143
|
-2.7 percent change
Interval -5.0 to 2.4
|
-5.4 percent change
Interval -20.9 to 11.4
|
0.0 percent change
Interval -4.9 to 8.0
|
NA percent change
Low-density lipoprotein was not collected at day 26 as per protocol
|
NA percent change
Low-density lipoprotein was not collected at day 26 as per protocol
|
|
Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99
Day 99
|
NA percent change
Low-density lipoprotein was not collected at day 99 as per protocol
|
NA percent change
Low-density lipoprotein was not collected at day 99 as per protocol
|
NA percent change
Only 1 patient was enrolled in cohort D, there was no day 99 visit for cohort D
|
0.7 percent change
Interval -9.8 to 13.5
|
-15.9 percent change
Interval -36.1 to -12.4
|
2.6 percent change
Interval -5.1 to 9.0
|
-19.0 percent change
Interval -19.0 to -19.0
|
-33.9 percent change
Interval -63.8 to -18.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set
Samples were taken following an overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline Total Cholesterol
|
201.0 mg/wk
Interval 165.0 to 237.0
|
207.0 mg/wk
Interval 176.0 to 213.0
|
263.0 mg/wk
Interval 263.0 to 263.0
|
208.0 mg/wk
Interval 191.0 to 245.0
|
220.5 mg/wk
Interval 189.0 to 248.0
|
107.0 mg/wk
Interval 93.0 to 115.0
|
231.0 mg/wk
Interval 231.0 to 231.0
|
199.0 mg/wk
Interval 171.0 to 208.0
|
SECONDARY outcome
Timeframe: Day 26 and Day 99Population: Full analysis set with last observation carried forward.
Samples were taken following an overnight fast.
Outcome measures
| Measure |
Cohort A: Placebo
n=2 Participants
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
|
Cohort A: Mipomersen
n=4 Participants
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort D
n=1 Participants
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
|
Cohort E: Placebo
n=10 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
|
Cohort E: Mipomersen
n=11 Participants
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
|
Cohort F: no Study Intervention
n=6 Participants
Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
|
Cohort G: Placebo Followed by Mipomersen
n=1 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
Cohort G: Mipomersen
n=3 Participants
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Day 99
Day 26
|
-3.5 percent change
Interval -7.9 to 0.8
|
-11.7 percent change
Interval -12.5 to -0.7
|
-29.5374 percent change
Interval -29.5374 to -29.5374
|
-3.1 percent change
Interval -16.9 to 10.1
|
0.1 percent change
Interval -2.1 to 3.0
|
1.4 percent change
Interval 0.0 to 2.7
|
NA percent change
Total cholesterol was not collected at day 26 as per protocol
|
NA percent change
Total cholesterol was not collected at day 26 as per protocol
|
|
Percent Change in Total Cholesterol From Baseline to Day 99
Day 99
|
NA percent change
Total cholesterol was not collected at day 99 as per protocol
|
NA percent change
Total cholesterol was not collected at day 99 as per protocol
|
NA percent change
Only 1 patient was enrolled in cohort D, there was no day 99 visit for cohort D
|
-11.8 percent change
Interval -24.2 to -9.7
|
-0.8 percent change
Interval -8.9 to 12.7
|
-0.4 percent change
Interval -6.9 to 4.3
|
-21.6 percent change
Interval -33.9 to -14.1
|
-21.6 percent change
Interval -33.9 to -14.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Mipomersen
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Not Treated
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo
|
Mipomersen
n=19 participants at risk
Mipomersen
|
Not Treated
n=6 participants at risk
Not Treated
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo
|
Mipomersen
n=19 participants at risk
Mipomersen
|
Not Treated
n=6 participants at risk
Not Treated
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Haematochezia
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Tooth disorder
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Chest discomfort
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Chills
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Fatigue
|
35.7%
5/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Feeling cold
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Influenza like illness
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
47.4%
9/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site discolouration
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site discomfort
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.3%
5/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site erythema
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
42.1%
8/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site haematoma
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site induration
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.8%
3/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site inflammation
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
47.4%
9/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site pallor
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site pruritus
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.8%
3/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site reaction
|
57.1%
8/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
52.6%
10/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Injection site swelling
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Malaise
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
General disorders
Pyrexia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Immune system disorders
Allergy to arthropod bite
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Influenza
|
21.4%
3/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Nasopharyngitis
|
35.7%
5/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
36.8%
7/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pertussis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pharyngitis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
15.8%
3/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Joint injury
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
33.3%
2/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
21.1%
4/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Protein urine present
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Carotid artery stenosis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Disturbance in attention
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Dizziness postural
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Headache
|
50.0%
7/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
26.3%
5/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Migraine
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Affect lability
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Psychiatric disorders
Listless
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Chromaturia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Renal and urinary disorders
Urine abnormality
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
10.5%
2/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
2/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
16.7%
1/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Hot flush
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
5.3%
1/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
|
Vascular disorders
Subclavian artery stenosis
|
7.1%
1/14
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/19
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
0.00%
0/6
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI gives Sponsor a draft 90 days before publication. Sponsor has the right to demand that confidential information be removed, and can defer publication another 180 days upon notifying PI that it will file a patent application on inventions contained in the draft.
- Publication restrictions are in place
Restriction type: OTHER