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| ID | Type | Description | Link |
|---|---|---|---|
| 16-H-0089 |
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Principal Investigator resigned and closed program
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Background:
Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease. Drugs called statins might shrink plaque. Researchers want to study how CT scanning can determine if an individuals arterial plaque has decreased while taking statins.
Objectives:
To measure the change in coronary artery plaque volume in people treated with high-intensity statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries. To determine how well plaque measurements from heart CT scans can be replicated.
Eligibility:
Men ages 40-75 and women ages 40-75 who are good candidates for statin treatment
Design:
Visit 1: participants will be screened with:
Participants will begin high-intensity statin treatment.
Participants will have 7 more visits over 3 years. All visits include blood tests and medication review. Some may also include:
Participants may join the PET Substudy. This includes 5 more visits during the study. These include:
Participants may join the Reproducibility Substudy if they had a slow heart rate during their first CT scan. This includes 1 additional heart CT scan 4 weeks later.
In high risk patients undergoing invasive angiography, intravascular ultrasound (IVUS) has shown reduction of plaque for patients treated with HMG-CoA reductase inhibitors (statins). However, there is no accepted noninvasive method to determine if treatment for atherosclerosis results in reduction of coronary artery plaque.
Coronary artery CT angiography (CCTA) is noninvasive and can accurately determine the degree of coronary artery stenosis. In addition, the extent of calcified and noncalcified plaque may be directly measured using this technology at low radiation dose using state-of-the-art CT scanners. Several retrospective studies have previously suggested that CCTA may be able to show plaque regression in the coronary arteries due to statin therapy.
The primary aim of this proposal is to determine the change in coronary artery plaque volume in individuals treated with high intensity statin therapy as defined by 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
Men and women who meet the inclusion and exclusion criteria will undergo CCTA examination for the presence or absence of coronary artery plaque. Individuals with evidence of noncalcified coronary plaque by CCTA and who meet criteria for HMG-CoA reductase (statin) therapy will be evaluated for a total of 36 months. The change of coronary artery plaque (progression or no change, or regression) in individuals with noncalcified plaque at baseline will be measured by CCTA at yearly intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate to High Statin Treatment in Participants with Coronary Artery Plaque | Other | Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Participants will receive 20-40 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography | Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C > or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately > or = 50%. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography | Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C > or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately > or = 50%. |
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A. Men greater than or equal to 40 and less than or equal to 75 years of age; women greater than or equal to 40 and less than or equal to 75 years of age
B. Willing to travel to the NIH for follow-up visits.
C. Willing to start or modify statin therapy.
D. Able to understand and sign informed consent.
E. Eligible for primary prevention statin therapy
(http://www.mesa-nhlbi.org/calcium/input.aspx).
EXCLUSION CRITERIA:
A. Allergy or prior clinically relevant adverse reaction to Rosuvastatin (does not include minor muscle pain).
B. High intensity statin treatment for more than 90 days prior to enrollment
C. LDL greater than or equal to 190 mg/ml
D. Physician-diagnosed heart attack
E. Physician-diagnosed stroke or TIA
F. Physician-diagnosed heart failure
G. Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
H. Active treatment for cancer
I. Prior hypersensitivity reaction to iodinated contrast injection
J. Known hyperthyroidism.
K. Acute renal failure, renal transplant, dialysis and renal failure clinically diagnosed.
L. History of liver transplant or severe liver disease or unexplained elevation of baseline ALT>3x upper limit of normal
M. Pregnancy and nursing
N. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.
O. Any other conditions that precludes safety for MRI and/or CT imaging per the researcher's evaluation.
P. Individuals with hemoglobinopathies or severe asthma.
Q. Severe renal excretory dysfunction, estimated glomerular filtration (eGFR) rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula: eGFR (mL/min/1.73m2) = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) or x 1.212 (if the subject is black)
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| Name | Affiliation | Role |
|---|---|---|
| Nehal N Mehta, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23206978 | Background | D'Ascenzo F, Agostoni P, Abbate A, Castagno D, Lipinski MJ, Vetrovec GW, Frati G, Presutti DG, Quadri G, Moretti C, Gaita F, Zoccai GB. Atherosclerotic coronary plaque regression and the risk of adverse cardiovascular events: a meta-regression of randomized clinical trials. Atherosclerosis. 2013 Jan;226(1):178-85. doi: 10.1016/j.atherosclerosis.2012.10.065. Epub 2012 Nov 6. | |
| 22883507 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate to High Statin Treatment in Participants With Coronary Artery Plaque | Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Moderate to High Statin Treatment in Participants With Coronary Artery Plaque | Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography | Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C > or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately > or = 50%. | Intention to treat analysis for those participants with observed plaque volumes by Coronary artery CT angiography at baseline and 24 months will be included in the primary analysis. | Posted | Mean | Standard Deviation | mm^3 | Baseline and 24 months |
Up to 36 months
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate to High Statin Treatment in Participants With Coronary Artery Plaque | Participants with coronary artery plaque will receive moderate to high statin treatment at either 20-40 mg once daily Rosuvastatin or 40-80 mg once daily of Atorvastatin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Protocol was terminated early due to departure of Principal Investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcus Chen | National Heart, Lung, and Blood Institute at the National Institutes of Health | 301.496.0077 | chenmy@nhlbi.nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2020 | Sep 21, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
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| Atorvastatin | Drug | Participants will receive 40-80 mg once daily. |
|
|
| Cardiac Computed Tomography (CT) | Radiation | Cardiac CT angiography (CCTA) provides a non-invasive method of evaluating both calcified and noncalcified plaque volume. Performed at baseline, 12 months 24 months, and 36 months. |
|
|
| Cardiac Magnetic Resonance Image (MRI) | Radiation | Provides a non-invasive method of evaluating both calcified and noncalcified plaque volume. Cardiac MRI may be performed at baseline, and 24 months (optional). |
|
|
| Baseline and 36 months |
| Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume | Linear mixed-effects regression coefficient of age effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one year increase of age. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Baseline, 24 months and 36 months |
| Linear Mixed-Effects Regression Coefficient of Sex Effect on Plaque Volume (Beta Coefficient) | Linear Mixed-effects Regression Coefficient of sex (female = 0 and male = 1) effect on plaque volume measured by Coronary artery CT angiography (beta coefficient). Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing male verses female (female =0 and male = 1). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Baseline, 24 months and 36 months |
| Linear Mixed-effects Regression Coefficient of Race Effect on Plaque Volume (Beta Coefficient) | Linear Mixed-effects Regression Coefficient of Effects race (white = 1 and non-white = 0) effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing race (white = 1 and non-white = 0). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Baseline, 24 months and 36 months |
| Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume | Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one kg/m^2 increase of BMI. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Baseline, 24 months and 36 months |
| Background |
| Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012 Aug 11;380(9841):565-71. doi: 10.1016/S0140-6736(12)61190-8. |
| 24239923 | Background | 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; 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. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
|
| Secondary | Mean Change of Non-calcified Plaque Volume in Participants Treated With High Intensity Statin Therapy Assessed by Coronary Computed Tomography Angiography | Mean change of non-calcified plaque volume assessed by Coronary computed tomography angiography in participants treated with high intensity statin therapy (as defined by the 2013 ACC/AHA Guidelines to Reduce Cardiovascular Risk (GRCR). Using anatomical landmarks, a target plaque volume will be defined at baseline and follow up examinations. Software will be used to trace lumen and outer vessel boundaries to determine non-calcified plaque volume. The 2013 ACC/AHA Guidelines to GRCR focuses on the assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk and management of elevated blood cholesterol and body weight in adults. High-intensity statin therapy is defined by: rosuvastatin 20-40 mg or atorvastatin 40-80 mg. The maximum statin dose will be administered that is tolerated by the patient and that maintains LDL-C > or = 25 mg/dl. High-intensity statin therapy is defined as lowering LDL-C on average by approximately > or = 50%. | Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline and 36 months will be included in the secondary analysis. | Posted | Mean | Standard Deviation | mm^3 | Baseline and 36 months |
|
|
|
|
| Secondary | Linear Mixed-effects Regression Coefficient of Age Effect on Plaque Volume | Linear mixed-effects regression coefficient of age effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one year increase of age. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis. | Posted | Mean | Standard Deviation | mm^3/year | Baseline, 24 months and 36 months |
|
|
|
|
| Secondary | Linear Mixed-Effects Regression Coefficient of Sex Effect on Plaque Volume (Beta Coefficient) | Linear Mixed-effects Regression Coefficient of sex (female = 0 and male = 1) effect on plaque volume measured by Coronary artery CT angiography (beta coefficient). Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing male verses female (female =0 and male = 1). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis. | Posted | Mean | Standard Deviation | beta coefficient [mm^3] | Baseline, 24 months and 36 months |
|
|
|
|
| Secondary | Linear Mixed-effects Regression Coefficient of Race Effect on Plaque Volume (Beta Coefficient) | Linear Mixed-effects Regression Coefficient of Effects race (white = 1 and non-white = 0) effect on plaque volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume comparing race (white = 1 and non-white = 0). In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis. | Posted | Mean | Standard Deviation | Beta coefficient [mm^3] | Baseline, 24 months and 36 months |
|
|
|
|
| Secondary | Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume | Linear Mixed-effects Regression Coefficient of Body Mass Index Effect on Plaque Volume measured by Coronary artery CT angiography. Plaque volumes (mm3) were quantified from coronary CTA exams using a validated automated method developed by Cleerly. Regression coefficient is the mean change of plaque volume given one kg/m^2 increase of BMI. In the mixed-effects model the outcomes are plaque volumes measured at Baseline, 24 months and 36 months as described in 2011 "Applied Longitudinal Analysis" Wiley Series in Probability and Statistics by Fitzmaurice, Laird, and Ware. | Intention to treat for those participants with observed plaque volumes by Coronary artery CT angiography at baseline, 24 months and 36 months will be included in the secondary analysis. | Posted | Mean | Standard Deviation | mm^3/[kg/m^2] | Baseline, 24 months and 36 months |
|
|
|
|
| 0 |
| 79 |
| 8 |
| 79 |
| 56 |
| 79 |
| Coronary stent placement | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Knee replacement | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Subaraschnoid hemorrhage | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic lymphocytic leukemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Varicosities | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Systolic murmur | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal infection | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Shoulder pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| H.pylori | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lip infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin A1C increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| LDL decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gout attack | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Prostatitis attack | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Right Iliotibial band syndrome | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Degenerative disc disease | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Lung nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Nodule in Right Lower Lobe | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Concussion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Foaming urine | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stage III Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythematous plaque and patches | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hip replacement | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |