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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004115-12 | EudraCT Number |
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The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label bempedoic acid | Experimental | bempedoic acid 180 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bempedoic acid | Drug | bempedoic acid 180 mg tablets taken orally, once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study. | Up to Week 82 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jedidiah Clinical Research | Tampa | Florida | 33607 | United States | ||
| L-MARC Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27892461 | Background | Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457. | |
| 24222016 | Background |
| Label | URL |
|---|---|
| World Health Organization Fact Sheet No. 317 | View source |
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After successfully completing 52 weeks of treatment in the parent study, Study 1002-040 (NCT02666664), and meeting entry criteria, participants could enrol into this Open-label Extension (OLE) study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo; Bempedoic Acid | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). |
| FG001 | Bempedoic Acid; Bempedoic Acid | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of bempedoic acid in the Open-Label Extension (OLE) Study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo; Bempedoic Acid | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study. | Safety Population: all enrolled participants who received at least 1 dose of bempedoic acid in the OLE Study | Posted | Count of Participants | Participants | Up to Week 82 |
|
Up to Week 82
Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo; Bempedoic Acid | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Esperion Therapeutics, Inc. | 1-833-377-7633 | medinfo@esperion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2018 | Oct 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2019 | Oct 29, 2020 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050197 | Atherosclerosis |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Baseline; Week 52 and Week 78 |
| Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 72 |
| Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Baseline; Week 52 and Week 78 |
| Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 72 |
| Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Percent Change From OLE Baseline ApoB at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Baseline; Week 52 and Week 78 |
| Louisville |
| Kentucky |
| 40213 |
| United States |
| Sentral Clinical Research Services | Cincinnati | Ohio | 45236 | United States |
| Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available. |
| 21600525 | Background | Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12. |
| 18537526 | Background | Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363. |
| 11535564 | Background | Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214. |
| Familial Hypercholesterolemia Foundation | View source |
| National Organization for Rare Disorders - Familial Hypercholesterolemia | View source |
| Adverse Event |
|
| Study Terminated by Sponsor or Investigator |
|
| Physician Decision |
|
| Other |
|
| BG001 | Bempedoic Acid; Bempedoic Acid | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Low-density lipoprotein cholesterol (LDL-C): Parent Study | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| Non-high-density lipoprotein cholesterol (N-HDL-C): Parent Study | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
|
| Total cholesterol: Parent Study | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
|
| Apolipoprotein B: Parent Study | Baseline was defined as the last value prior to first dose of study drug. | Only participants with non-missing data were analysed. | Mean | Standard Deviation | mg/dL |
|
| High-sensitivity C-reactive protein (hs-CRP): Parent Study | Baseline was defined as the last value prior to the first dose of study drug. | Only participants with non-missing data were analysed. | Median | Inter-Quartile Range | milligrams per Liter (mg/L) |
|
| Triglycerides: Parent Study | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Median | Inter-Quartile Range | mg/dL |
|
| High-density lipoprotein cholesterol (HDL-C): Parent Study | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
|
| LDL-C: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Mean | Standard Deviation | mg/dL |
|
| N-HDL-C: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Mean | Standard Deviation | mg/dL |
|
| Total cholesterol: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Mean | Standard Deviation | mg/dL |
|
| Apolipoprotein B: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Mean | Standard Deviation | mg/dL |
|
| hs-CRP: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Median | Inter-Quartile Range | mg/L |
|
| Triglycerides: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Median | Inter-Quartile Range | mg/dL |
|
| HDL-C: OLE Study | Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Mean | Standard Deviation | mg/dL |
|
| OG001 | Bempedoic Acid; Bempedoic Acid | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| OG002 | OLE Bempedoic Acid | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
|
|
| Secondary | Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 72 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 52 and Week 72 |
|
|
|
| Secondary | Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From OLE Baseline ApoB at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| Secondary | Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 and Week 78 |
|
|
|
| 3 |
| 492 |
| 97 |
| 492 |
| 108 |
| 492 |
| EG001 | Bempedoic Acid; Bempedoic Acid | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | 10 | 970 | 202 | 970 | 201 | 970 |
| EG002 | OLE Bempedoic Acid | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | 13 | 1,462 | 299 | 1,462 | 309 | 1,462 |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lymph node tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Hypergammaglobulinaemia benign monoclonal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung carcinoma cell type unspecified stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Non-small cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Papillary renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Toxic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| External compression headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Angiodysplasia | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Accidental death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Brain death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vascular stent occlusion | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vascular stent thrombosis | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral artery restenosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Stress echocardiogram abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Ultrasound ovary abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Splenic haematoma | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Adrenal cyst | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
|
| Multiple endocrine neoplasia Type 1 | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
|
| Device malfunction | Product Issues | MedDRA 20.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anginal equivalent | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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