Trial Outcomes & Findings for The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy (NCT NCT02527343)
NCT ID: NCT02527343
Last Updated: 2021-10-18
Results Overview
Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 predose fasting assessment. Month 3 value was defined as the average of Week 12 and Week 13 fasting TG assessments of the randomized treatment period. The data was analyzed using an analysis of covariance (ANCOVA) model with the randomization stratification factor (diagnosis of disease with or without genetics and family history) and treatment group as factors and log-transformed baseline fasting TG as a covariate.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Baseline to Month 3
Results posted on
2021-10-18
Participant Flow
The study was conducted at 12 study centers in the United States, Russia, Brazil, Germany, Belgium, Canada, and Netherlands from 28 December 2015 to 13 November 2019.
A total of 40 participants were randomized into this study.
Participant milestones
| Measure |
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a subcutaneous (SC) injection once-weekly from Weeks 1 to 52 of the randomized treatment (RT) period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Post-Treatment Follow-up Period: Placebo
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period.
|
Randomized Post-Treatment Follow-up Period: Volanesorsen
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
|---|---|---|---|---|---|---|
|
RT Period: Weeks 1 to 52
STARTED
|
19
|
21
|
0
|
0
|
0
|
0
|
|
RT Period: Weeks 1 to 52
COMPLETED
|
13
|
14
|
0
|
0
|
0
|
0
|
|
RT Period: Weeks 1 to 52
NOT COMPLETED
|
6
|
7
|
0
|
0
|
0
|
0
|
|
RT Post Treatment Follow-up: Weeks 54-65
STARTED
|
0
|
0
|
7
|
9
|
0
|
0
|
|
RT Post Treatment Follow-up: Weeks 54-65
COMPLETED
|
0
|
0
|
6
|
7
|
0
|
0
|
|
RT Post Treatment Follow-up: Weeks 54-65
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
|
OLE Period-Year 1: Week 53 to 104
STARTED
|
0
|
0
|
0
|
0
|
12
|
12
|
|
OLE Period-Year 1: Week 53 to 104
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
3
|
|
OLE Period-Year 1: Week 53 to 104
NOT COMPLETED
|
0
|
0
|
0
|
0
|
11
|
9
|
|
OLE Period-Year 2: Week 105 to 156
STARTED
|
0
|
0
|
0
|
0
|
1
|
2
|
|
OLE Period-Year 2: Week 105 to 156
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
OLE Period-Year 2: Week 105 to 156
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
|
PT Follow-up: Weeks 104 to 169
STARTED
|
0
|
0
|
0
|
0
|
12
|
12
|
|
PT Follow-up: Weeks 104 to 169
COMPLETED
|
0
|
0
|
0
|
0
|
11
|
11
|
|
PT Follow-up: Weeks 104 to 169
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Randomized Treatment Period: Placebo
Participants received volanesorsen-matching placebo as a subcutaneous (SC) injection once-weekly from Weeks 1 to 52 of the randomized treatment (RT) period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Post-Treatment Follow-up Period: Placebo
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period.
|
Randomized Post-Treatment Follow-up Period: Volanesorsen
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
|---|---|---|---|---|---|---|
|
RT Period: Weeks 1 to 52
Investigator Judgement
|
1
|
0
|
0
|
0
|
0
|
0
|
|
RT Period: Weeks 1 to 52
Voluntary withdrawal
|
1
|
0
|
0
|
0
|
0
|
0
|
|
RT Period: Weeks 1 to 52
Adverse Event (AE) or Serious Adverse Event (SAE)
|
0
|
4
|
0
|
0
|
0
|
0
|
|
RT Period: Weeks 1 to 52
Other
|
4
|
3
|
0
|
0
|
0
|
0
|
|
RT Post Treatment Follow-up: Weeks 54-65
AE or SAE
|
0
|
0
|
1
|
0
|
0
|
0
|
|
RT Post Treatment Follow-up: Weeks 54-65
Other
|
0
|
0
|
0
|
2
|
0
|
0
|
|
OLE Period-Year 1: Week 53 to 104
Investigator Judgement
|
0
|
0
|
0
|
0
|
1
|
0
|
|
OLE Period-Year 1: Week 53 to 104
Voluntary Withdrawal
|
0
|
0
|
0
|
0
|
3
|
1
|
|
OLE Period-Year 1: Week 53 to 104
AE or SAE
|
0
|
0
|
0
|
0
|
2
|
1
|
|
OLE Period-Year 1: Week 53 to 104
Other
|
0
|
0
|
0
|
0
|
5
|
7
|
|
OLE Period-Year 2: Week 105 to 156
Other
|
0
|
0
|
0
|
0
|
1
|
2
|
|
PT Follow-up: Weeks 104 to 169
Voluntary withdrawal
|
0
|
0
|
0
|
0
|
1
|
0
|
|
PT Follow-up: Weeks 104 to 169
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Number analyzed signifies the number of participants with data available for hepatic fat fraction.
Baseline characteristics by cohort
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 12 • n=19 Participants
|
46 years
STANDARD_DEVIATION 10 • n=21 Participants
|
47 years
STANDARD_DEVIATION 11 • n=40 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=19 Participants
|
15 Participants
n=21 Participants
|
29 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=19 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=19 Participants
|
20 Participants
n=21 Participants
|
38 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=19 Participants
|
20 Participants
n=21 Participants
|
37 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Other Race
|
1 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=40 Participants
|
|
Fasting Triglycerides
|
1290.95 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1296.19 • n=19 Participants
|
1241.31 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1090.83 • n=21 Participants
|
1264.89 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1177.40 • n=40 Participants
|
|
Hepatic Fat Fraction
|
17.00 percentage (Hepatic Fat Fraction)
STANDARD_DEVIATION 7.52 • n=16 Participants • Number analyzed signifies the number of participants with data available for hepatic fat fraction.
|
18.10 percentage (Hepatic Fat Fraction)
STANDARD_DEVIATION 8.41 • n=17 Participants • Number analyzed signifies the number of participants with data available for hepatic fat fraction.
|
17.57 percentage (Hepatic Fat Fraction)
STANDARD_DEVIATION 7.88 • n=33 Participants • Number analyzed signifies the number of participants with data available for hepatic fat fraction.
|
|
Hemoglobin A1c
|
8.25 percentage of HbA1c
STANDARD_DEVIATION 1.13 • n=19 Participants
|
7.84 percentage of HbA1c
STANDARD_DEVIATION 1.62 • n=21 Participants
|
8.04 percentage of HbA1c
STANDARD_DEVIATION 1.40 • n=40 Participants
|
|
Short Form-36 (SF-36) Weighted Sum of Scores
|
48.51 score on a scale
STANDARD_DEVIATION 12.83 • n=16 Participants • Number analyzed signifies the number of participants with data available for SF-36 weighted sum of scores.
|
46.31 score on a scale
STANDARD_DEVIATION 12.83 • n=17 Participants • Number analyzed signifies the number of participants with data available for SF-36 weighted sum of scores.
|
47.38 score on a scale
STANDARD_DEVIATION 12.45 • n=33 Participants • Number analyzed signifies the number of participants with data available for SF-36 weighted sum of scores.
|
|
EQ-5D Questionnaires: Index Scores
|
0.83 score on a scale
STANDARD_DEVIATION 0.20 • n=12 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: Index Scores.
|
0.84 score on a scale
STANDARD_DEVIATION 0.18 • n=17 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: Index Scores.
|
0.83 score on a scale
STANDARD_DEVIATION 0.19 • n=29 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: Index Scores.
|
|
EQ-5D Questionnaires: Visual Analog Scale
|
70 score on a scale
STANDARD_DEVIATION 18 • n=12 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: VAS.
|
71 score on a scale
STANDARD_DEVIATION 18 • n=17 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: VAS.
|
71 score on a scale
STANDARD_DEVIATION 17 • n=29 Participants • Number analyzed signifies the number of participants with data available for EQ-5D Questionnaires: VAS.
|
PRIMARY outcome
Timeframe: Baseline to Month 3Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. This outcome measure is reported here for the randomized treatment period only, as per the planned analysis.
Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 predose fasting assessment. Month 3 value was defined as the average of Week 12 and Week 13 fasting TG assessments of the randomized treatment period. The data was analyzed using an analysis of covariance (ANCOVA) model with the randomization stratification factor (diagnosis of disease with or without genetics and family history) and treatment group as factors and log-transformed baseline fasting TG as a covariate.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG)
|
-21.64 percent change
Interval -60.85 to 17.57
|
-88.47 percent change
Interval -133.56 to -43.38
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment.
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Randomized treatment period: Month 6 value was defined as Week 25 or Week 26 for MRI assessment and Month 12 was defined as Week 50 or Week 52 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using Magnetic Resonance Imaging (MRI)
Percent Change at Month 12
|
1.46 percent change
Interval -30.49 to 33.42
|
-51.87 percent change
Interval -87.87 to -15.87
|
|
Randomized Treatment Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using Magnetic Resonance Imaging (MRI)
Percent Change at Month 6
|
2.83 percent change
Interval -23.46 to 29.12
|
-22.86 percent change
Interval -52.07 to 6.34
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12Population: FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Baseline was defined as the last non-missing assessment prior to the first dose of study drug in the randomized treatment period. Open-label extension period: Month 6 value was defined as Week 77 or Week 78 for MRI assessment and Month 12 value was defined as Week 102 or Week 104 for MRI assessment. Hepatic steatosis is a reversible condition in which large vacuoles of triglyceride fat accumulate in the liver cells, causing nonspecific inflammation. Hepatic Steatosis was assessed by hepatic fat fraction using MRI.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=12 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=12 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open-Label Extension Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using MRI
Percent Change at Month 6
|
-18.4 percent change
Standard Deviation 54.7
|
-60.2 percent change
Standard Deviation 43.6
|
|
Open-Label Extension Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using MRI
Percent Change at Month 12
|
-93.5 percent change
Standard Deviation 44.4
|
-22.1 percent change
Standard Deviation 47.5
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, and 12Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment.
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: The Month 3 value was defined as Week 13, Month 6 value was defined as Week 26, Month 9 value was defined as Week 38 and Month 12 value was defined as Week 52.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Change at Month 3
|
-0.51 percentage of HbA1c
Interval -1.22 to 0.2
|
-0.21 percentage of HbA1c
Interval -1.0 to 0.58
|
|
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Change at Month 6
|
0.06 percentage of HbA1c
Interval -1.02 to 1.15
|
0.26 percentage of HbA1c
Interval -0.98 to 1.5
|
|
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Change at Month 9
|
0.68 percentage of HbA1c
Interval -0.49 to 1.85
|
0.48 percentage of HbA1c
Interval -0.84 to 1.8
|
|
Randomized Treatment Period: Change From Baseline in Hemoglobin A1c (HbA1c)
Change at Month 12
|
0.48 percentage of HbA1c
Interval -0.49 to 1.45
|
0.28 percentage of HbA1c
Interval -0.78 to 1.35
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, and 12Population: FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
Baseline was defined as the last non-missing assessment prior to the first dose of study drug. Open-label extension period: Month 3 value was defined as Week 65, Month 6 value was defined as Week 78, Month 9 value was defined as Week 90 and Month 12 value was defined as Week 104.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=12 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=12 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open Label Extension Period: Change From Baseline in HbA1c
Change at Month 6
|
0.35 percentage of HbA1c
Standard Deviation 1.54
|
-0.75 percentage of HbA1c
Standard Deviation 0.35
|
|
Open Label Extension Period: Change From Baseline in HbA1c
Change at Month 3
|
0.42 percentage of HbA1c
Standard Deviation 1.54
|
0.91 percentage of HbA1c
Standard Deviation 2.18
|
|
Open Label Extension Period: Change From Baseline in HbA1c
Change at Month 9
|
0.35 percentage of HbA1c
Standard Deviation 1.06
|
-0.05 percentage of HbA1c
Standard Deviation 0.64
|
|
Open Label Extension Period: Change From Baseline in HbA1c
Change at Month 12
|
0.00 percentage of HbA1c
Standard Deviation 0.71
|
0.30 percentage of HbA1c
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. This outcome measure is reported here for the randomized treatment period only, as per the planned analysis.
The baseline of TG is defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. The baseline of hepatic fat fraction is defined as the last non-missing assessment prior to the first dose of study drug. Randomized treatment period: Month 6 value was defined as average of Week 25 and Week 26 for fasting TG and Week 25 or Week 26 for hepatic fat fraction.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Percentage of Participants Who Achieved Greater Than or Equal to (≥) 40% Reduction in Fasting Triglyceride and ≥ 30% Reduction of Hepatic Fat Fraction at Month 6
|
5.3 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug to Week 52Population: Data for this outcome measure was not collected due to the change in planned analysis.
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first dose of study drug in open label extension period to Week 117Population: Data for this outcome measure was not collected due to the change in planned analysis.
The Disease Burden Score is a questionnaire that allows participants to self-report their chronic conditions and then assess the degree to which each condition interferes with daily activities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first dose of study drug up to Week 52Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=20 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Patient-Reported Pain
Normal Work
|
2.37 score on a scale
Standard Deviation 2.84
|
2.89 score on a scale
Standard Deviation 2.56
|
|
Randomized Treatment Period: Patient-Reported Pain
Rate Pain at its Worst Last 24 Hours
|
3.28 score on a scale
Standard Deviation 2.79
|
3.57 score on a scale
Standard Deviation 2.72
|
|
Randomized Treatment Period: Patient-Reported Pain
Rate Pain at its Least Last 24 Hours
|
2.45 score on a scale
Standard Deviation 2.46
|
2.59 score on a scale
Standard Deviation 2.43
|
|
Randomized Treatment Period: Patient-Reported Pain
Rate Pain on Average
|
3.08 score on a scale
Standard Deviation 2.62
|
3.16 score on a scale
Standard Deviation 2.47
|
|
Randomized Treatment Period: Patient-Reported Pain
Rate Pain Right Now
|
2.72 score on a scale
Standard Deviation 2.59
|
2.96 score on a scale
Standard Deviation 2.50
|
|
Randomized Treatment Period: Patient-Reported Pain
General Activity
|
2.43 score on a scale
Standard Deviation 2.80
|
2.83 score on a scale
Standard Deviation 2.57
|
|
Randomized Treatment Period: Patient-Reported Pain
Interfere With Mood
|
2.31 score on a scale
Standard Deviation 2.88
|
2.98 score on a scale
Standard Deviation 2.59
|
|
Randomized Treatment Period: Patient-Reported Pain
Walking Ability
|
2.35 score on a scale
Standard Deviation 2.96
|
2.79 score on a scale
Standard Deviation 2.59
|
|
Randomized Treatment Period: Patient-Reported Pain
Relations With Other People
|
2.23 score on a scale
Standard Deviation 2.79
|
2.62 score on a scale
Standard Deviation 2.67
|
|
Randomized Treatment Period: Patient-Reported Pain
Sleep
|
2.75 score on a scale
Standard Deviation 2.95
|
2.73 score on a scale
Standard Deviation 2.75
|
|
Randomized Treatment Period: Patient-Reported Pain
Enjoyment of Life
|
2.42 score on a scale
Standard Deviation 2.82
|
2.68 score on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: From the first dose of study drug in open label extension period up to Week 117Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Patient-reported pain was assessed by rating pain symptoms at its worst and least for the last 24 hours, on average, and at the moment, with 0 as the lowest score (no pain) and 10 as the highest score (worst pain as you can imagine). Patient-reported pain was also assessed by rating pain symptoms (rate pain on average, rate pain right now) that interfered with general activity, interfered with mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, with 0 as the lowest score (did not interfered) and 10 as the highest score (completely interfered). The scores from each assessment time point were averaged for all of the below reported categories.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=9 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=9 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open Label Extension Period: Patient-Reported Pain
Rate Pain at its Worst Last 24 Hours
|
1.70 score on a scale
Standard Deviation 1.18
|
3.82 score on a scale
Standard Deviation 2.97
|
|
Open Label Extension Period: Patient-Reported Pain
Rate Pain at its Least Last 24 Hours
|
0.95 score on a scale
Standard Deviation 1.04
|
2.78 score on a scale
Standard Deviation 2.60
|
|
Open Label Extension Period: Patient-Reported Pain
Rate Pain on Average
|
1.35 score on a scale
Standard Deviation 1.22
|
3.16 score on a scale
Standard Deviation 2.72
|
|
Open Label Extension Period: Patient-Reported Pain
Rate Pain Right Now
|
1.28 score on a scale
Standard Deviation 1.18
|
3.49 score on a scale
Standard Deviation 2.99
|
|
Open Label Extension Period: Patient-Reported Pain
General Activity
|
1.03 score on a scale
Standard Deviation 1.45
|
3.28 score on a scale
Standard Deviation 2.90
|
|
Open Label Extension Period: Patient-Reported Pain
Interfere With Mood
|
1.27 score on a scale
Standard Deviation 1.46
|
3.23 score on a scale
Standard Deviation 2.94
|
|
Open Label Extension Period: Patient-Reported Pain
Walking Ability
|
1.05 score on a scale
Standard Deviation 1.50
|
3.51 score on a scale
Standard Deviation 2.83
|
|
Open Label Extension Period: Patient-Reported Pain
Normal Work
|
1.08 score on a scale
Standard Deviation 1.40
|
3.48 score on a scale
Standard Deviation 2.98
|
|
Open Label Extension Period: Patient-Reported Pain
Relations With Other People
|
1.08 score on a scale
Standard Deviation 1.48
|
3.18 score on a scale
Standard Deviation 3.09
|
|
Open Label Extension Period: Patient-Reported Pain
Sleep
|
1.51 score on a scale
Standard Deviation 1.83
|
3.13 score on a scale
Standard Deviation 3.35
|
|
Open Label Extension Period: Patient-Reported Pain
Enjoyment of Life
|
1.23 score on a scale
Standard Deviation 1.65
|
3.33 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to Week 52Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=20 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Patient-Reported Hunger
How Hungry You Feel
|
29.4 score on a scale
Standard Deviation 20.7
|
29.6 score on a scale
Standard Deviation 14.4
|
|
Randomized Treatment Period: Patient-Reported Hunger
How Satisfied You Feel
|
56.8 score on a scale
Standard Deviation 22.4
|
57.5 score on a scale
Standard Deviation 15.1
|
|
Randomized Treatment Period: Patient-Reported Hunger
How Full You Feel
|
62.6 score on a scale
Standard Deviation 20.5
|
56.6 score on a scale
Standard Deviation 18.4
|
|
Randomized Treatment Period: Patient-Reported Hunger
How Much You Think You Can Eat
|
33.6 score on a scale
Standard Deviation 22.1
|
36.8 score on a scale
Standard Deviation 15.4
|
|
Randomized Treatment Period: Patient-Reported Hunger
Like to Eat Something Sweet
|
71.0 score on a scale
Standard Deviation 20.8
|
54.8 score on a scale
Standard Deviation 27.1
|
|
Randomized Treatment Period: Patient-Reported Hunger
Like to Eat Something Salty
|
66.9 score on a scale
Standard Deviation 21.7
|
69.0 score on a scale
Standard Deviation 20.2
|
|
Randomized Treatment Period: Patient-Reported Hunger
Like to Eat Something Savory
|
65.2 score on a scale
Standard Deviation 21.4
|
66.8 score on a scale
Standard Deviation 21.9
|
|
Randomized Treatment Period: Patient-Reported Hunger
Like to Eat Something Fatty
|
77.9 score on a scale
Standard Deviation 18.4
|
75.9 score on a scale
Standard Deviation 22.2
|
|
Randomized Treatment Period: Patient-Reported Hunger
Visual Appeal
|
28.6 score on a scale
Standard Deviation 20.5
|
34.5 score on a scale
Standard Deviation 21.0
|
|
Randomized Treatment Period: Patient-Reported Hunger
Smell
|
23.4 score on a scale
Standard Deviation 16.2
|
25.4 score on a scale
Standard Deviation 15.5
|
|
Randomized Treatment Period: Patient-Reported Hunger
Taste
|
25.5 score on a scale
Standard Deviation 18.3
|
29.1 score on a scale
Standard Deviation 14.5
|
|
Randomized Treatment Period: Patient-Reported Hunger
Aftertaste
|
58.9 score on a scale
Standard Deviation 27.5
|
51.0 score on a scale
Standard Deviation 24.6
|
|
Randomized Treatment Period: Patient-Reported Hunger
Palatability
|
31.3 score on a scale
Standard Deviation 20.1
|
32.2 score on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: From the first dose of study drug in open label extension period up to Week 117Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Patient-reported hunger was assessed by participants who completed a questionnaire about: how hungry you feel, how satisfied you feel, how full you feel, how much you think you can eat, like to eat something sweet, like to eat something salty, like to eat something savory and like to eat something fatty. Participants also rated the palatability of meals that included visual appeal, smell, taste, and aftertaste. Scores of 1-39 were categorized as mild, 40-69 as moderate, and 70-100 as severe. The scores from each assessment time point were averaged for all of the below reported categories.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=9 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=9 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open Label Extension Period: Patient-Reported Hunger
How Hungry You Feel
|
29.9 score on a scale
Standard Deviation 23.3
|
33.2 score on a scale
Standard Deviation 23.2
|
|
Open Label Extension Period: Patient-Reported Hunger
How Satisfied You Feel
|
54.2 score on a scale
Standard Deviation 23.3
|
56.3 score on a scale
Standard Deviation 20.2
|
|
Open Label Extension Period: Patient-Reported Hunger
How Full You Feel
|
59.7 score on a scale
Standard Deviation 22.2
|
52.9 score on a scale
Standard Deviation 24.4
|
|
Open Label Extension Period: Patient-Reported Hunger
How Much You Think You Can Eat
|
34.0 score on a scale
Standard Deviation 21.8
|
34.9 score on a scale
Standard Deviation 21.5
|
|
Open Label Extension Period: Patient-Reported Hunger
Like to Eat Something Sweet
|
73.7 score on a scale
Standard Deviation 25.4
|
57.9 score on a scale
Standard Deviation 24.0
|
|
Open Label Extension Period: Patient-Reported Hunger
Like to Eat Something Salty
|
65.7 score on a scale
Standard Deviation 28.1
|
61.9 score on a scale
Standard Deviation 22.1
|
|
Open Label Extension Period: Patient-Reported Hunger
Like to Eat Something Savory
|
65.4 score on a scale
Standard Deviation 24.7
|
62.7 score on a scale
Standard Deviation 30.5
|
|
Open Label Extension Period: Patient-Reported Hunger
Like to Eat Something Fatty
|
80.7 score on a scale
Standard Deviation 18.1
|
68.0 score on a scale
Standard Deviation 30.4
|
|
Open Label Extension Period: Patient-Reported Hunger
Visual Appeal
|
14.9 score on a scale
Standard Deviation 16.1
|
35.3 score on a scale
Standard Deviation 25.9
|
|
Open Label Extension Period: Patient-Reported Hunger
Smell
|
13.1 score on a scale
Standard Deviation 14.3
|
29.6 score on a scale
Standard Deviation 21.6
|
|
Open Label Extension Period: Patient-Reported Hunger
Taste
|
13.6 score on a scale
Standard Deviation 15.1
|
32.9 score on a scale
Standard Deviation 25.0
|
|
Open Label Extension Period: Patient-Reported Hunger
Aftertaste
|
48.1 score on a scale
Standard Deviation 38.6
|
56.9 score on a scale
Standard Deviation 29.3
|
|
Open Label Extension Period: Patient-Reported Hunger
Palatability
|
24.4 score on a scale
Standard Deviation 23.4
|
37.3 score on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13, 26 and 52Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Emotional Role Functioning: Change at Week 26
|
-2.90 score on a scale
Standard Deviation 6.44
|
0.23 score on a scale
Standard Deviation 7.50
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Vitality: Change at Week 13
|
-1.14 score on a scale
Standard Deviation 7.33
|
-0.21 score on a scale
Standard Deviation 5.64
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Vitality: Change at Week 26
|
-0.25 score on a scale
Standard Deviation 9.00
|
-0.79 score on a scale
Standard Deviation 6.89
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Vitality: Change at Week 52
|
-0.85 score on a scale
Standard Deviation 6.11
|
-3.30 score on a scale
Standard Deviation 8.20
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Functioning: Change at Week 13
|
-0.29 score on a scale
Standard Deviation 4.81
|
-0.41 score on a scale
Standard Deviation 3.91
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Functioning: Change at Week 26
|
-0.64 score on a scale
Standard Deviation 6.49
|
0.51 score on a scale
Standard Deviation 5.29
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Functioning: Change at Week 52
|
-3.55 score on a scale
Standard Deviation 4.05
|
-2.76 score on a scale
Standard Deviation 5.25
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Bodily Pain: Change at Week 13
|
-0.46 score on a scale
Standard Deviation 7.97
|
0.75 score on a scale
Standard Deviation 6.26
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Bodily Pain: Change at Week 26
|
-1.98 score on a scale
Standard Deviation 12.24
|
0.19 score on a scale
Standard Deviation 4.27
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Bodily Pain: Change at Week 52
|
-0.29 score on a scale
Standard Deviation 6.35
|
-2.55 score on a scale
Standard Deviation 8.48
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
General Health Perceptions: Change at Week 13
|
-0.55 score on a scale
Standard Deviation 5.57
|
-0.58 score on a scale
Standard Deviation 4.04
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
General Health Perceptions: Change at Week 26
|
-1.59 score on a scale
Standard Deviation 5.00
|
0.54 score on a scale
Standard Deviation 7.25
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
General Health Perceptions: Change at Week 52
|
-1.50 score on a scale
Standard Deviation 6.74
|
-1.48 score on a scale
Standard Deviation 4.53
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Role Functioning: Change at Week 13
|
-0.52 score on a scale
Standard Deviation 5.44
|
-0.64 score on a scale
Standard Deviation 4.61
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Role Functioning: Change at Week 26
|
-2.06 score on a scale
Standard Deviation 10.81
|
0.75 score on a scale
Standard Deviation 4.70
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Physical Role Functioning: Change at Week 52
|
-0.32 score on a scale
Standard Deviation 2.02
|
-2.00 score on a scale
Standard Deviation 7.05
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Emotional Role Functioning: Change at Week 13
|
-1.88 score on a scale
Standard Deviation 4.63
|
0.75 score on a scale
Standard Deviation 6.85
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Emotional Role Functioning : Change at Week 52
|
-1.00 score on a scale
Standard Deviation 5.94
|
-5.42 score on a scale
Standard Deviation 5.80
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Social Role Functioning: Change at Week 13
|
-3.86 score on a scale
Standard Deviation 9.85
|
1.07 score on a scale
Standard Deviation 4.02
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Social Role Functioning: Change at Week 26
|
-5.01 score on a scale
Standard Deviation 9.07
|
-0.67 score on a scale
Standard Deviation 3.21
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Social Role Functioning: Change at Week 52
|
2.87 score on a scale
Standard Deviation 4.89
|
-2.79 score on a scale
Standard Deviation 7.14
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Mental Health: Change at Week 13
|
0.00 score on a scale
Standard Deviation 6.67
|
-0.19 score on a scale
Standard Deviation 7.91
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Mental Health: Change at Week 26
|
-2.18 score on a scale
Standard Deviation 7.71
|
1.05 score on a scale
Standard Deviation 6.76
|
|
Randomized Treatment Period: Change From Baseline in Mean Short Form-36 (SF-36) Weighted Sum of Scores
Mental Health: Change at Week 52
|
-0.37 score on a scale
Standard Deviation 6.66
|
-1.75 score on a scale
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Baseline, Weeks 65, 78 and 104Population: FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. SF-36 consists of 8 health dimensions,which are weighted sums of the questions in each section. SF-36 included 36 questions related to 8 health dimensions:physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning,emotional role functioning, and mental health. Each dimension was scored on a scale of 0 to 100 where, higher score = better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=12 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=12 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Vitality: Change at Week 65
|
4.46 score on a scale
Standard Deviation 6.30
|
-0.42 score on a scale
Standard Deviation 13.88
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Vitality: Change at Week 78
|
-2.98 score on a scale
Standard Deviation 12.61
|
-2.97 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Vitality: Change at Week 104
|
2.97 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-5.94 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Functioning: Change at Week 65
|
-4.79 score on a scale
Standard Deviation 6.77
|
-1.37 score on a scale
Standard Deviation 5.81
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Functioning: Change at Week 78
|
-3.83 score on a scale
Standard Deviation 5.41
|
0.00 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Functioning: Change at Week 104
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-1.91 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Bodily Pain: Change at Week 65
|
-2.42 score on a scale
Standard Deviation 3.42
|
0.40 score on a scale
Standard Deviation 7.13
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Bodily Pain: Change at Week 78
|
-7.26 score on a scale
Standard Deviation 19.39
|
-11.29 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Bodily Pain: Change at Week 104
|
6.45 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-10.49 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
General Health Perceptions: Change at Week 65
|
2.38 score on a scale
Standard Deviation 3.36
|
-2.38 score on a scale
Standard Deviation 4.42
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
General Health Perceptions: Change at Week 78
|
-2.86 score on a scale
Standard Deviation 7.40
|
-4.75 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
General Health Perceptions: Change at Week 104
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-4.75 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Role Functioning: Change at Week 65
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-0 score on a scale
Standard Deviation 6.22
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Role Functioning: Change at Week 78
|
-10.11 score on a scale
Standard Deviation 14.29
|
-2.25 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Physical Role Functioning: Change at Week 104
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-4.50 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Emotional Role Functioning: Change at Week 65
|
-1.74 score on a scale
Standard Deviation 2.46
|
-3.48 score on a scale
Standard Deviation 11.37
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Emotional Role Functioning: Change at Week 78
|
1.74 score on a scale
Standard Deviation 2.46
|
-10.45 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Emotional Role Functioning: Change at Week 104
|
3.48 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-10.45 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Social Role Functioning: Change at Week 65
|
5.02 score on a scale
Standard Deviation 7.09
|
-2.15 score on a scale
Standard Deviation 7.58
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Social Role Functioning: Change at Week 78
|
-2.15 score on a scale
Standard Deviation 7.09
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Social Role Functioning: Change at Week 104
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Mental Health: Change at Week 65
|
-5.23 score on a scale
Standard Deviation 11.10
|
-1.12 score on a scale
Standard Deviation 13.67
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Mental Health: Change at Week 78
|
6.54 score on a scale
Standard Deviation 9.25
|
-15.70 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean SF-36 Weighted Sum of Scores
Mental Health: Change at Week 104
|
2.62 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 13, 26 and 52Population: FAS included all participants who were randomized and received at least one dose of study drug in the randomized treatment period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=19 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
Index Score: Change at Week 13
|
0.05 score on a scale
Standard Deviation 0.10
|
-0.02 score on a scale
Standard Deviation 0.06
|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
Index Score: Change at Week 26
|
-0.11 score on a scale
Standard Deviation 0.19
|
-0.02 score on a scale
Standard Deviation 0.12
|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
Index Score: Change at Week 52
|
-0.08 score on a scale
Standard Deviation 0.10
|
-0.05 score on a scale
Standard Deviation 0.07
|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
EQ VAS Score: Change at Week 13
|
-2 score on a scale
Standard Deviation 13
|
-2 score on a scale
Standard Deviation 15
|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
EQ VAS Score: Change at Week 26
|
-11 score on a scale
Standard Deviation 17
|
-2 score on a scale
Standard Deviation 14
|
|
Randomized Treatment Period: Change From Baseline in Mean EQ-5D: Index Scores and Visual Analog Scale (VAS)
EQ VAS Score: Change at Week 52
|
-13 score on a scale
Standard Deviation 18
|
-4 score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 65, 78 and 104Population: FAS included all participants who were randomized and received at least one dose of study drug in the open-label extension period, and who had a baseline fasting TG assessment. Here, "number analyzed" signifies participants evaluable for this outcome measure at specified time points.
EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of two components: a health state profile and VAS. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L- VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. A negative change from baseline indicates worsening. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Randomized Treatment Period: Placebo
n=12 Participants
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=12 Participants
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
|---|---|---|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
Index Score: Change at Week 65
|
—
|
-0.06 score on a scale
Standard Deviation 0.08
|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
Index Score: Change at Week 78
|
-0.02 score on a scale
Standard Deviation 0.03
|
-0.07 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
Index Score: Change at Week 104
|
0.00 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
-0.27 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
EQ VAS Score: Change at Week 65
|
—
|
-4 score on a scale
Standard Deviation 16
|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
EQ VAS Score: Change at Week 78
|
-15 score on a scale
Standard Deviation 22
|
-6 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Open-Label Extension Period: Change From Baseline in Mean EQ-5D: Index and Visual Analog Scale (VAS) Scores
EQ VAS Score: Change at Week 104
|
2 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
0 score on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
Adverse Events
Randomized Treatment Period: Placebo
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Randomized Treatment Period: Volanesorsen
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Randomized Post-Treatment Follow-up: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Randomized Post-Treatment Follow-up: Volanesorsen
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Treatment Period: Placebo
n=19 participants at risk
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 participants at risk
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Post-Treatment Follow-up: Placebo
n=7 participants at risk
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the OLE period went straight to the 13-week post-treatment follow-up period.
|
Randomized Post-Treatment Follow-up: Volanesorsen
n=9 participants at risk
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
n=12 participants at risk
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
n=12 participants at risk
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
1/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Medical device site inflammation
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
Other adverse events
| Measure |
Randomized Treatment Period: Placebo
n=19 participants at risk
Participants received volanesorsen-matching placebo as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Treatment Period: Volanesorsen
n=21 participants at risk
Participants received 300 mg of volanesorsen as a SC injection once-weekly from Weeks 1 to 52 of the randomized treatment period. Participants were allowed dose adjustment based on monitoring rules.
|
Randomized Post-Treatment Follow-up: Placebo
n=7 participants at risk
Following the randomized treatment period, participants who received volanesorsen-matching placebo in randomized treatment period and did not enter the OLE period went straight to the 13-week post-treatment follow-up period.
|
Randomized Post-Treatment Follow-up: Volanesorsen
n=9 participants at risk
Following the randomized treatment period, participants who received 300 mg of volanesorsen in randomized treatment period and did not enter in the OLE period went straight to the 13-week post-treatment follow-up period.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Placebo/Volanesorsen
n=12 participants at risk
Participants in the Randomized Treatment Period: Placebo arm group who completed the randomized treatment period, were to receive 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
Open-Label Extension Period (OLE and OLE Post-Treatment Follow-up): Volanesorsen/Volanesorsen
n=12 participants at risk
Participants in the Randomized Treatment Period: Volanesorsen arm group who completed the randomized treatment period, received 300 mg of volanesorsen as a SC injection once-weekly for 52 weeks (from Weeks 53 to 104) in the OLE period. Participants were allowed dose adjustment based on monitoring rules. After Week 104 of the OLE period, participants had the option of continuing treatment with 300 mg of volanesorsen as a SC injection for up to an additional 52 weeks (from Week 105 to 156). Participants who were not entered in the option for an additional 52 weeks of dosing in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of the first 52 weeks (from Weeks 53 to 104) of the OLE. Participants who were entered in the OLE post-treatment period went straight to a 13-week post-treatment follow-up period after completion of Week 156 of the OLE.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
22.2%
2/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
28.6%
2/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Influenza
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Peripheral swelling
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
1/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
1/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site extravasation
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
11.1%
1/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.1%
4/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
23.8%
5/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
28.6%
6/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Fungal infection
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Infection
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Bacterial vaginosis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Candida infection
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Hordeolum
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Oral candidiasis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Subcutaneous abscess
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site erythema
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
61.9%
13/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
58.3%
7/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site pruritus
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
52.4%
11/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
25.0%
3/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site pain
|
15.8%
3/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
33.3%
7/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
33.3%
4/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site swelling
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
38.1%
8/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
50.0%
6/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Fatigue
|
15.8%
3/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Chest pain
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site bruising
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
25.0%
3/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site discolouration
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site mass
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site rash
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site nodule
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site induration
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
25.0%
3/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Pain
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site warmth
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Chills
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site discomfort
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
26.3%
5/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
19.0%
4/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
19.0%
4/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
19.0%
4/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
25.0%
3/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
33.3%
4/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
19.0%
4/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Subileus
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Epulis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.3%
5/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Platelet count decreased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
23.8%
5/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Haemoglobin decreased
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Protein total increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood magnesium decreased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Cardiac murmur
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
International normalised ratio increased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood glucose fluctuation
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood potassium decreased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood urine present
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Glucose urine
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Haematocrit decreased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Red blood cells urine
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Urine protein, quantitative
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Urine protein/creatinine ratio increased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
White blood cell count decreased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
White blood cell count increased
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Synovial fluid white blood cells positive
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Rheumatoid factor increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood pressure increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Biopsy muscle
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Bacterial test
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Albumin urine present
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
19.0%
4/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
25.0%
3/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Amnesia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Dysstasia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Chest injury
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Concussion
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Injury
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Eye disorders
Cataract
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Eye disorders
Eye swelling
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Eye disorders
Ocular discomfort
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Eye disorders
Ocular hyperaemia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Eye disorders
Visual impairment
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Proteinuria
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Chromaturia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Micturition urgency
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
14.3%
3/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
9.5%
2/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Sleep-related eating disorder
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Cardiac disorders
Atrioventricular block second degree
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
4.8%
1/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Reproductive system and breast disorders
Vulval disorder
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Immune system disorders
Hypersensitivity
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Surgical and medical procedures
Sinus operation
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Surgical and medical procedures
Asthma prophylaxis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
16.7%
2/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.3%
1/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/19 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/21 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/7 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/9 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
8.3%
1/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
0.00%
0/12 • From first dose of study drug to end of follow-up period [Up to Week 169]
Safety Population Set 1 included all participants who were randomized and received at least one dose of study drug (volanesorsen or placebo) in the randomized treatment period. Safety Population Set 2 included all participants who entered the OLE Period and received at least one dose of study drug (volanesorsen) in the OLE period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place