Trial Outcomes & Findings for A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol (NCT NCT01475825)
NCT ID: NCT01475825
Last Updated: 2019-03-26
Results Overview
The percent change from baseline to PET in LDL-C was measured in Cohort 1, which included participants with severe heterozygous familial hypercholesterolemia (HeFH). Severe HeFH was defined as LDL-C levels ≥200 mg/deciliter (dL) plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
309 participants
Primary outcome timeframe
Baseline and Week 61
Results posted on
2019-03-26
Participant Flow
Participant milestones
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
Participants received once weekly subcutaneous (SC) injections of mipomersen sodium 200 milligrams (mg) during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
51
|
102
|
52
|
|
Overall Study
Randomized and Treated
|
104
|
51
|
102
|
52
|
|
Overall Study
Completed Blinded Treatment Period
|
60
|
42
|
59
|
40
|
|
Overall Study
Entered Open-Label Continuation
|
45
|
31
|
44
|
29
|
|
Overall Study
Completed Open-Label Continuation
|
37
|
19
|
38
|
22
|
|
Overall Study
COMPLETED
|
37
|
19
|
38
|
22
|
|
Overall Study
NOT COMPLETED
|
67
|
32
|
64
|
30
|
Reasons for withdrawal
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
Participants received once weekly subcutaneous (SC) injections of mipomersen sodium 200 milligrams (mg) during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
41
|
15
|
27
|
11
|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
2
|
4
|
0
|
|
Overall Study
Other: Not available
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
11
|
7
|
|
Overall Study
Did not enter OLC
|
15
|
11
|
15
|
11
|
Baseline Characteristics
The full analysis set was analyzed in two cohorts, shown below.
Baseline characteristics by cohort
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=104 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=51 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=102 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=52 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.36 years
STANDARD_DEVIATION 9.766 • n=104 Participants
|
55.49 years
STANDARD_DEVIATION 10.481 • n=51 Participants
|
53.15 years
STANDARD_DEVIATION 11.918 • n=102 Participants
|
54.38 years
STANDARD_DEVIATION 9.939 • n=52 Participants
|
54.85 years
STANDARD_DEVIATION 10.53 • n=309 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=104 Participants
|
29 Participants
n=51 Participants
|
54 Participants
n=102 Participants
|
27 Participants
n=52 Participants
|
168 Participants
n=309 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=104 Participants
|
22 Participants
n=51 Participants
|
48 Participants
n=102 Participants
|
25 Participants
n=52 Participants
|
141 Participants
n=309 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=104 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
6 Participants
n=52 Participants
|
18 Participants
n=309 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=104 Participants
|
45 Participants
n=51 Participants
|
95 Participants
n=102 Participants
|
46 Participants
n=52 Participants
|
285 Participants
n=309 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=104 Participants
|
2 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
0 Participants
n=52 Participants
|
6 Participants
n=309 Participants
|
|
LDL-C Baseline Values
Cohort 1
|
262 mg/dL
STANDARD_DEVIATION 103.1 • n=67 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
255 mg/dL
STANDARD_DEVIATION 75.0 • n=34 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
274 mg/dL
STANDARD_DEVIATION 75.1 • n=66 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
263 mg/dL
STANDARD_DEVIATION 82.9 • n=33 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=200 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
|
LDL-C Baseline Values
Cohort 2
|
177 mg/dL
STANDARD_DEVIATION 20.8 • n=37 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
179 mg/dL
STANDARD_DEVIATION 25.6 • n=17 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
178 mg/dL
STANDARD_DEVIATION 17.6 • n=36 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
169 mg/dL
STANDARD_DEVIATION 26.6 • n=19 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=109 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
|
Apolipoprotein B Baseline Values
Cohort 1
|
172 mg/dL
STANDARD_DEVIATION 52.1 • n=67 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
170 mg/dL
STANDARD_DEVIATION 35.0 • n=34 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
182 mg/dL
STANDARD_DEVIATION 37.9 • n=66 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
174 mg/dL
STANDARD_DEVIATION 45.2 • n=33 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=200 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
|
Apolipoprotein B Baseline Values
Cohort 2
|
131 mg/dL
STANDARD_DEVIATION 17.3 • n=37 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
134 mg/dL
STANDARD_DEVIATION 17.0 • n=17 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
135 mg/dL
STANDARD_DEVIATION 16.3 • n=36 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
128 mg/dL
STANDARD_DEVIATION 23.4 • n=19 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=109 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
|
Lipoprotein (a) Baseline Values
Cohort 1
|
43 mg/dL
STANDARD_DEVIATION 39.5 • n=67 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
50 mg/dL
STANDARD_DEVIATION 45.6 • n=34 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
38 mg/dL
STANDARD_DEVIATION 40.3 • n=66 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
51 mg/dL
STANDARD_DEVIATION 50.8 • n=33 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=200 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
|
Lipoprotein (a) Baseline Values
Cohort 2
|
52 mg/dL
STANDARD_DEVIATION 58.4 • n=37 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
48 mg/dL
STANDARD_DEVIATION 65.6 • n=17 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
59 mg/dL
STANDARD_DEVIATION 49.3 • n=36 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
27 mg/dL
STANDARD_DEVIATION 28.2 • n=19 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
NA mg/dL
STANDARD_DEVIATION NA • n=109 Participants • The full analysis set was analyzed in two cohorts, shown below.
|
PRIMARY outcome
Timeframe: Baseline and Week 61Population: The full analysis set for Cohort 1 included all randomized participants who took at least 1 dose of study drug in Cohort 1 (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in LDL-C was measured in Cohort 1, which included participants with severe heterozygous familial hypercholesterolemia (HeFH). Severe HeFH was defined as LDL-C levels ≥200 mg/deciliter (dL) plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=67 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=34 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=66 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=33 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To Primary Endpoint Visit (PET) In LDL-C In Cohort 1
|
-27.17 Percent
Standard Error 5.653
|
-6.77 Percent
Standard Error 6.749
|
-22.96 Percent
Standard Error 5.362
|
-10.62 Percent
Standard Error 5.765
|
SECONDARY outcome
Timeframe: Baseline, PET (up to 60 weeks)Population: The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in LDL-C was measured in Cohort 2, which included participants with HeFH with LDL-C levels ≥160 mg/dL and \<200 mg/dL, plus the presence of CHD/risk equivalents.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=37 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=17 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=36 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=19 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To PET In LDL-C In Cohort 2
|
-31.20 Percent
Standard Error 8.927
|
-9.25 Percent
Standard Error 10.621
|
-43.60 Percent
Standard Error 8.342
|
-13.57 Percent
Standard Error 9.066
|
SECONDARY outcome
Timeframe: Baseline and Week 61Population: The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in Apo B was measured in participants in Cohort 1 with HeFH during the Blinded Treatment Period.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=67 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=34 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=66 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=33 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To PET In Apolipoprotein B (Apo B) In Cohort 1
|
-24.14 Percent
Standard Error 5.058
|
-2.83 Percent
Standard Error 6.115
|
-21.43 Percent
Standard Error 4.861
|
-7.28 Percent
Standard Error 5.309
|
SECONDARY outcome
Timeframe: Baseline and Week 61Population: The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in Apo B was measured in participants in Cohort 2 with HeFH during the Blinded Treatment Period.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=37 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=17 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=36 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=19 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To PET In Apolipoprotein B (Apo B) In Cohort 2
|
-30.76 Percent
Standard Error 7.309
|
-6.67 Percent
Standard Error 8.758
|
-36.34 Percent
Standard Error 7.039
|
-3.77 Percent
Standard Error 8.109
|
SECONDARY outcome
Timeframe: Baseline and Week 61Population: The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in Lipoprotein A1 was measured in participants in Cohort 1 with HeFH during the Blinded Treatment Period.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=67 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=34 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=66 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=33 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To PET in Lipoprotein (a) In Cohort 1
|
-18.84 Percent
Standard Error 7.870
|
-16.85 Percent
Standard Error 9.959
|
-27.18 Percent
Standard Error 5.497
|
-10.08 Percent
Standard Error 5.992
|
SECONDARY outcome
Timeframe: Baseline and Week 61Population: The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.
The percent change from baseline to PET in Lipoprotein A1 was measured in participants in Cohort 2 with HeFH during the Blinded Treatment Period.
Outcome measures
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=37 Participants
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=17 Participants
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=36 Participants
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=19 Participants
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Percent Change From Baseline To PET in Lipoprotein (a) In Cohort 2
|
-23.41 Percent
Standard Error 10.002
|
-11.86 Percent
Standard Error 11.871
|
-35.56 Percent
Standard Error 11.846
|
18.79 Percent
Standard Error 15.271
|
Adverse Events
Regimen A: Mipomersen, 200 mg, Once Weekly
Serious events: 17 serious events
Other events: 82 other events
Deaths: 1 deaths
Regimen A: Placebo, Once Weekly
Serious events: 13 serious events
Other events: 27 other events
Deaths: 0 deaths
Regimen B: Mipomersen, 70 mg, Thrice Weekly
Serious events: 23 serious events
Other events: 78 other events
Deaths: 1 deaths
Regimen B: Placebo, Thrice Weekly
Serious events: 11 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=104 participants at risk
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=51 participants at risk
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=102 participants at risk
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=52 participants at risk
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
6.7%
7/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.8%
4/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.7%
4/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Angina unstable
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
4/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
2/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.8%
2/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Coronary artery disease
|
2.9%
3/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Non-cardiac chest pain
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
2/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Chest pain
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
2/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Death
|
1.9%
2/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Asthenia
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Drug intolerance
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Influenza like illness
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Pyrexia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Device related infection
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Embolism venous
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Hypertension
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Renal and urinary disorders
Haematuria
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Renal and urinary disorders
Renal cyst
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Helicobacter test negative
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.98%
1/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
Other adverse events
| Measure |
Regimen A: Mipomersen, 200 mg, Once Weekly
n=104 participants at risk
Participants received once weekly SC injections of mipomersen sodium 200 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen A: Placebo, Once Weekly
n=51 participants at risk
Participants received once weekly SC injections of Placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Mipomersen, 70 mg, Thrice Weekly
n=102 participants at risk
Participants received thrice weekly SC injections of mipomersen sodium 70 mg during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
Regimen B: Placebo, Thrice Weekly
n=52 participants at risk
Participants received thrice weekly SC injections of placebo during the 60-week Blinded Treatment Period, continued the dosing regimen during the 26-week Open-Label Continuation Period, and then entered the 24-week Post-Treatment Period.
|
|---|---|---|---|---|
|
General disorders
Influenza like illness
|
41.3%
43/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
19.6%
10/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
25.5%
26/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
19.2%
10/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Injection site erythema
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
12.7%
13/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Injection site pain
|
12.5%
13/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Injection site swelling
|
3.8%
4/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.8%
8/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
General disorders
Injection site pruritus
|
2.9%
3/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
7/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.8%
4/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
13.5%
7/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Influenza
|
4.8%
5/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
8.8%
9/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
9.6%
5/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
2/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.8%
4/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.8%
2/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Bronchitis
|
4.8%
5/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Infections and infestations
Urinary tract infection
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
20.2%
21/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
17.6%
18/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
16.3%
17/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
10.8%
11/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
C-reactive protein increased
|
3.8%
4/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Hepatic enzyme increased
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
4/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.96%
1/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
4/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
4.9%
5/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
6/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.7%
4/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
4/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
5/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Headache
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
2/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
8.8%
9/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
7.7%
4/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Nervous system disorders
Dizziness
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.9%
3/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Angina pectoris
|
7.7%
8/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
9.8%
5/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
4/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
11.5%
6/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Cardiac disorders
Palpitations
|
1.9%
2/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
2/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Nausea
|
8.7%
9/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
6.9%
7/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.8%
2/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
9.6%
10/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
1/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
8.8%
9/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
1.9%
1/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Vascular disorders
Hypertension
|
2.9%
3/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.9%
3/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
3.9%
4/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
9.6%
5/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
5/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
4.9%
5/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/104 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
0.00%
0/51 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
2.0%
2/102 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
5.8%
3/52 • Adverse events were monitored from the time of the administration of the participant's first dose of study drug (mipomersen or placebo) through the participant's last visit of the Post-Treatment Period, up to Week 110.
Adverse events were collected for all randomized participants who received at least 1 dose of study drug (mipomersen or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60