Trial Outcomes & Findings for Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (NCT NCT02993406)
NCT ID: NCT02993406
Last Updated: 2024-01-03
Results Overview
The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis.
COMPLETED
PHASE3
13970 participants
Up to 68 months
2024-01-03
Participant Flow
This was a randomized, double-blind, placebo-controlled, parallel-group study that assessed the occurrence of major adverse cardiovascular event (MACE) in participants with, or at high risk for, cardiovascular disease (CVD) who were unable to tolerate statin therapy.
A total of 13970 participants were enrolled from over 1250 sites in 32 countries.
Participant milestones
| Measure |
Bempedoic Acid 180 Milligrams (mg)
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Overall Study
STARTED
|
6992
|
6978
|
|
Overall Study
COMPLETED
|
6697
|
6620
|
|
Overall Study
NOT COMPLETED
|
295
|
358
|
Reasons for withdrawal
| Measure |
Bempedoic Acid 180 Milligrams (mg)
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
170
|
196
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
12
|
13
|
|
Overall Study
Unclassifiable Response
|
105
|
139
|
|
Overall Study
Administrative decision
|
1
|
0
|
|
Overall Study
Sponsor decision
|
4
|
5
|
Baseline Characteristics
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
Baseline characteristics by cohort
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
Total
n=13970 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
65.5 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
65.5 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3361 Participants
n=5 Participants
|
3379 Participants
n=7 Participants
|
6740 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3631 Participants
n=5 Participants
|
3599 Participants
n=7 Participants
|
7230 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1190 Participants
n=5 Participants
|
1143 Participants
n=7 Participants
|
2333 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5802 Participants
n=5 Participants
|
5835 Participants
n=7 Participants
|
11637 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
240 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
487 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
130 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
156 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6397 Participants
n=5 Participants
|
6335 Participants
n=7 Participants
|
12732 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
48 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
|
819 Participants
|
927 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
The first key secondary end point was a three-component MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With First Occurrence of Three Component MACE
|
575 Participants
|
663 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
Number of participants with time to first occurrence of fatal and non-fatal myocardial infarction are presented.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With First Occurrence of Myocardial Infarction
|
261 Participants
|
334 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
Number of participants with time to first occurrence of coronary revascularization are presented.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of Coronary Revascularization
|
435 Participants
|
529 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
Number of participants with time to first occurrence of fatal and non-fatal stroke.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With Time to First Occurrence of Stroke
|
135 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
Number of participants with time to cardiovascular death are presented.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With Time to Cardiovascular Death
|
269 Participants
|
257 Participants
|
SECONDARY outcome
Timeframe: Up to 68 monthsPopulation: Intention-to-Treat Population.
All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.
Outcome measures
| Measure |
Bempedoic Acid 180 mg
n=6992 Participants
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6978 Participants
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Number of Participants With Time to All-cause Mortality
|
434 Participants
|
420 Participants
|
Adverse Events
Bempedoic Acid 180 mg
Placebo Comparator
Serious adverse events
| Measure |
Bempedoic Acid 180 mg
n=7001 participants at risk
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6964 participants at risk
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
11/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Angina pectoris
|
0.80%
56/7001 • Number of events 62 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
1.2%
82/6964 • Number of events 84 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Angina unstable
|
0.80%
56/7001 • Number of events 58 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.76%
53/6964 • Number of events 54 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Anginal equivalent
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.17%
12/7001 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Arrhythmia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
81/7001 • Number of events 107 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
1.4%
95/6964 • Number of events 111 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
14/7001 • Number of events 17 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrial tachycardia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
7/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Bradycardia
|
0.13%
9/7001 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
COVID-19
|
0.80%
56/7001 • Number of events 56 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
1.1%
75/6964 • Number of events 76 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
3/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
35/7001 • Number of events 43 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.55%
38/6964 • Number of events 46 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac failure acute
|
0.27%
19/7001 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.29%
20/6964 • Number of events 28 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.23%
16/7001 • Number of events 16 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.19%
13/6964 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
39/7001 • Number of events 42 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.53%
37/6964 • Number of events 45 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac valve disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiogenic shock
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
2/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
25/7001 • Number of events 26 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.47%
33/6964 • Number of events 34 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Extrasystoles
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Left ventricular failure
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
28/7001 • Number of events 28 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.50%
35/6964 • Number of events 35 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.14%
10/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Myocarditis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Palpitations
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Pericardial cyst
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Pericardial effusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Pericarditis
|
0.09%
6/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Sinus arrest
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Sinus bradycardia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
14/7001 • Number of events 14 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.14%
10/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Tachycardia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Trifascicular block
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
9/7001 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.20%
14/6964 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Congenital ectopic pancreas
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Hereditary neuropathic amyloidosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Intestinal malrotation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Trisomy 18
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Congenital, familial and genetic disorders
Uterine cervix canal atresia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Goitre
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Hyperthyroidism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Thyroid mass
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Amblyopia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.09%
6/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Diplopia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Macular fibrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Macular hole
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Macular rupture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Retinal vascular occlusion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Retinal vein occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Anal fistula
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Anal polyp
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Appendicitis noninfective
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Constipation
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Duodenitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Dysphagia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
22/7001 • Number of events 25 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.30%
21/6964 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Haematochezia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Hiatus hernia, obstructive
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Nausea
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.13%
9/7001 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.14%
10/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Stomach granuloma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Chest discomfort
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Complication associated with device
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Complication of device insertion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
11/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.23%
16/6964 • Number of events 16 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Facial pain
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Fatigue
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
General physical health deterioration
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Impaired healing
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Medical device site joint inflammation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Non-cardiac chest pain
|
0.71%
50/7001 • Number of events 55 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.82%
57/6964 • Number of events 60 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Oedema peripheral
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Pain
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Pyrexia
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Strangulated hernia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Swelling
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Swelling face
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Treatment failure
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Ulcer haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Vascular stent stenosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Vessel puncture site haematoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Ampulla of Vater stenosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Asthenia
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
6/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Biliary colic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
General disorders
Chest pain
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.14%
10/6964 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
38/7001 • Number of events 39 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.22%
15/6964 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholestasis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Heart transplant rejection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Abscess intestinal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Abscess oral
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Acute HIV infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Anal abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Appendiceal abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Appendicitis
|
0.27%
19/7001 • Number of events 19 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Appendicitis perforated
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
3/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Arthritis infective
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Babesiosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Biliary sepsis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Bronchitis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Bronchitis viral
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.2%
84/7001 • Number of events 86 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
1.3%
90/6964 • Number of events 90 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cardiac valve vegetation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.33%
23/7001 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.23%
16/6964 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cellulitis
|
0.16%
11/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.30%
21/6964 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Chronic sinusitis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Clostridium difficile infection
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Complicated appendicitis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cystitis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Cystitis klebsiella
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Dengue fever
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Device related bacteraemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Device related infection
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Diabetic foot infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Diarrhoea infectious
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Diverticulitis
|
0.27%
19/7001 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.39%
27/6964 • Number of events 35 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Encephalitis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Endophthalmitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Enterobacter sepsis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Enterococcal sepsis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Erysipelas
|
0.06%
4/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gangrene
|
0.10%
7/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastroenteritis
|
0.14%
10/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastroenteritis viral
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastroenteritis yersinia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Giardiasis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Groin abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Helicobacter infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Herpes zoster
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Herpes zoster oticus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infected bite
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infected skin ulcer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Influenza
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Kidney infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Klebsiella sepsis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Large intestine infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Liver abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Localised infection
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Lung abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Myelitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Necrotising fasciitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Orchitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Osteomyelitis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Osteomyelitis acute
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Parotitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pericarditis infective
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Perirectal abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Peritonitis
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pilonidal cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia
|
1.2%
84/7001 • Number of events 93 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
1.2%
81/6964 • Number of events 92 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia bacterial
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia influenzal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia legionella
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Post procedural cellulitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Postoperative abscess
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pulmonary sepsis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pyelonephritis
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Rectal abscess
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Rhinovirus infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Sepsis
|
0.34%
24/7001 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.32%
22/6964 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Septic shock
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Soft tissue infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Staphylococcal infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Suspected COVID-19
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Syncope
|
0.33%
23/7001 • Number of events 25 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.39%
27/6964 • Number of events 28 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Syphilis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Systemic infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
23/7001 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.47%
33/6964 • Number of events 34 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Urosepsis
|
0.10%
7/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Vestibular neuronitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Viral infection
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Viral myocarditis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Viral pericarditis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Wound infection
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication cardiac
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.34%
24/7001 • Number of events 33 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.39%
27/6964 • Number of events 33 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
6/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Joint capsule rupture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Lisfranc fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Pharynx radiation injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Poisoning deliberate
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post intensive care syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative hypertension
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.31%
22/7001 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.42%
29/6964 • Number of events 30 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Underdose
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
pain
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Angiocardiogram
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Angiogram
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Aspiration pleural cavity
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Bacterial test
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Biopsy lung
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Blindness transient
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood bicarbonate decreased
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood potassium increased
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood pressure increased
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood urea increased
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood uric acid increased
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Cardiac stress test abnormal
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Cataract
|
0.17%
12/7001 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Ejection fraction decreased
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Glaucoma
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Glomerular filtration rate decreased
|
0.04%
3/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Haemoglobin decreased
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Influenza B virus test positive
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Investigation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Eye disorders
Retinal detachment
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
SARS-CoV-2 test positive
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Transaminases increased
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Troponin increased
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Weight decreased
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.27%
19/7001 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.22%
15/6964 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
6/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Gout
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Obesity
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
13/7001 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Cartilage hypertrophy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.06%
4/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.17%
12/7001 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.22%
15/6964 • Number of events 16 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
8/7001 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.14%
10/7001 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
71/7001 • Number of events 81 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.99%
69/6964 • Number of events 75 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.16%
11/7001 • Number of events 17 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
13/7001 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.23%
16/6964 • Number of events 20 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.14%
10/7001 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.16%
11/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Thoracic spinal stenosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.09%
6/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
13/7001 • Number of events 14 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.17%
12/6964 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
16/7001 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chest wall tumour
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
6/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoplastic melanoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid sarcoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.01%
1/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioblastoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Juvenile melanoma benign
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage II
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage III
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage III
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.19%
13/7001 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mesenteric neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal neoplasm benign
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian endometrioid carcinoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage II
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer stage III
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer metastatic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Axonal neuropathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Balance disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Basilar artery aneurysm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Basilar artery occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
9/7001 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Brain oedema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
14/7001 • Number of events 14 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.33%
23/6964 • Number of events 24 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carotid artery disease
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.07%
5/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
21/7001 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.36%
25/6964 • Number of events 25 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Coma
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Delayed ischaemic neurological deficit
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Dementia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Dizziness
|
0.10%
7/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Dysarthria
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Encephalitis toxic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Encephalopathy
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Epilepsy
|
0.07%
5/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Frontotemporal dementia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Headache
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Hemiparesis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Hydrocephalus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Hyperglycaemic unconsciousness
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Ischaemic stroke
|
0.14%
10/7001 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.20%
14/6964 • Number of events 14 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Lacunar infarction
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Migraine
|
0.04%
3/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Monoplegia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Myasthenia gravis
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Nerve compression
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Optic neuritis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Paresis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Polyneuropathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Presyncope
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.27%
19/7001 • Number of events 19 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.30%
21/6964 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Radiculopathy
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Sciatica
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Seizure
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Spinal claudication
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Spinal cord compression
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Spinal cord herniation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Status epilepticus
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Tension headache
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Transient global amnesia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.59%
41/7001 • Number of events 43 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.52%
36/6964 • Number of events 36 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vascular dementia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device breakage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device dislocation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device end of service
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device failure
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device lead damage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device loosening
|
0.01%
1/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device malfunction
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Product Issues
Device occlusion
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Delirium
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Emotional distress
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Sleep disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Stress
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Suicide attempt
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
8/7001 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Calculus urinary
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
18/7001 • Number of events 21 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.20%
14/6964 • Number of events 16 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
17/7001 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.27%
19/6964 • Number of events 19 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.03%
2/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.24%
17/7001 • Number of events 26 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.22%
15/6964 • Number of events 17 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal disorder
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal failure
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal hypertension
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal impairment
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal mass
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urate nephropathy
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
2/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urge incontinence
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.26%
18/7001 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.20%
14/6964 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Cystocele
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Prostatism
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Reproductive system and breast disorders
Vulvovaginal adhesion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
35/7001 • Number of events 37 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.42%
29/6964 • Number of events 32 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.26%
18/7001 • Number of events 18 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.42%
29/6964 • Number of events 32 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
9/7001 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma late onset
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Combined pulmonary fibrosis and emphysema
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
11/7001 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.20%
14/6964 • Number of events 15 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Renal and urinary disorders
Haematuria
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum haematoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate abnormality
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
7/7001 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.01%
1/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
6/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchial dyskinesia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Adiposis dolorosa
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Anxiety
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Depression
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Major depression
|
0.03%
2/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Peau d'orange
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Social circumstances
Amputee
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Social circumstances
Cardiac assistance device user
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Social circumstances
Cardiac valve prosthesis user
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Accelerated hypertension
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
13/7001 • Number of events 13 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic dissection
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic stenosis
|
0.19%
13/7001 • Number of events 14 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Arteriovenous fistula
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Brachiocephalic artery stenosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Circulatory collapse
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.27%
19/6964 • Number of events 20 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Dry gangrene
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Embolism arterial
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Essential hypertension
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Extremity necrosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
7/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.11%
8/6964 • Number of events 9 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
7/7001 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.14%
10/6964 • Number of events 10 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Giant cell arteritis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Haematoma
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.11%
8/7001 • Number of events 8 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypertension
|
0.41%
29/7001 • Number of events 29 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.37%
26/6964 • Number of events 30 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
16/7001 • Number of events 16 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 12 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypertensive emergency
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypertensive urgency
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.09%
6/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypotension
|
0.07%
5/7001 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.16%
11/6964 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypovolaemic shock
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Iliac artery stenosis
|
0.06%
4/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Intermittent claudication
|
0.03%
2/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.04%
3/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Orthostatic hypotension
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Penetrating atherosclerotic ulcer
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.43%
30/7001 • Number of events 43 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.36%
25/6964 • Number of events 40 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.04%
3/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.07%
5/6964 • Number of events 6 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.04%
3/7001 • Number of events 3 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral embolism
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral ischaemia
|
0.07%
5/7001 • Number of events 5 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.10%
7/6964 • Number of events 7 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.04%
3/7001 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.13%
9/6964 • Number of events 11 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Renovascular hypertension
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Shock
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Shock haemorrhagic
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Thrombophlebitis
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Thrombosis
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.03%
2/6964 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Varicose vein
|
0.03%
2/7001 • Number of events 2 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.06%
4/6964 • Number of events 4 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Varicose vein ruptured
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Vasospasm
|
0.01%
1/7001 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.00%
0/6964 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/7001 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
0.01%
1/6964 • Number of events 1 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
Other adverse events
| Measure |
Bempedoic Acid 180 mg
n=7001 participants at risk
Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
|
Placebo Comparator
n=6964 participants at risk
Participants were administered with matching Placebo tablet once daily orally.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
10.4%
731/7001 • Number of events 756 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
11.5%
801/6964 • Number of events 826 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
539/7001 • Number of events 802 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
7.4%
515/6964 • Number of events 784 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
351/7001 • Number of events 424 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
5.6%
389/6964 • Number of events 462 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
548/7001 • Number of events 675 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
8.0%
554/6964 • Number of events 722 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
404/7001 • Number of events 458 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
6.5%
450/6964 • Number of events 511 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
392/7001 • Number of events 511 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
6.7%
470/6964 • Number of events 599 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.9%
763/7001 • Number of events 868 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
5.6%
393/6964 • Number of events 435 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.5%
458/7001 • Number of events 509 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
6.2%
435/6964 • Number of events 475 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Investigations
Blood uric acid increased
|
5.6%
393/7001 • Number of events 439 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
2.7%
186/6964 • Number of events 201 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Nervous system disorders
Headache
|
6.8%
479/7001 • Number of events 572 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
7.1%
493/6964 • Number of events 574 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
|
Vascular disorders
Hypertension
|
10.7%
747/7001 • Number of events 907 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
|
11.5%
804/6964 • Number of events 978 • Up to 68 months. Serious adverse events (SAEs) and non-SAEs were collected from Safety Population. The Safety Population comprises of all randomized participants who received at least 1 dose of study medication (investigational product). Deaths were endpoints and not reported as SAEs. Negatively adjudicated non- fatal MACE events were reported as SAEs.
The Safety Analysis Set (SAS) included all participants in the Full Analysis Set who received at least 1 dose of study drug. Participants in the SAS were grouped according to the actual treatment received. Out of 5 participants, 2 randomized to bempedoic acid and 3 to placebo, did not receive any treatment \& were not included in the SAS; 11 participants were randomized to placebo but received ≥ to 1 dose of bempedoic acid in error, and were therefore, counted in bempedoic acid group for the SAS.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
- Publication restrictions are in place
Restriction type: OTHER