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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

13970 participants

Primary outcome timeframe

Up to 68 months

Results posted on

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

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: Intention-to-Treat Population.

Number of participants with time to first occurrence of fatal and non-fatal myocardial infarction are presented.

Outcome measures

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 months

Population: Intention-to-Treat Population.

Number of participants with time to first occurrence of coronary revascularization are presented.

Outcome measures

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 months

Population: Intention-to-Treat Population.

Number of participants with time to first occurrence of fatal and non-fatal stroke.

Outcome measures

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 months

Population: Intention-to-Treat Population.

Number of participants with time to cardiovascular death are presented.

Outcome measures

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 months

Population: 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

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

Serious events: 1767 serious events
Other events: 5805 other events
Deaths: 437 deaths

Placebo Comparator

Serious events: 1733 serious events
Other events: 5490 other events
Deaths: 420 deaths

Serious adverse events

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

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.

Additional Information

Medical Director

Esperion Therapeutics, Inc.

Phone: 1-833-377-7633

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