Body mass index
Item
1. bmi greater than or equal to 27 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Compliance behavior Low-Calorie Diet | Compliance behavior Increased physical activity levels
Item
2. subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
boolean
C1321605 (UMLS CUI [1,1])
C2930544 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0851792 (UMLS CUI [2,2])
Age | Cardiovascular Disease
Item
3. age greater than or equal to 40 years with established cv disease as defined by one of the following:
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Myocardial Infarction | Ischemic stroke
Item
1. history of documented mi or ischemic stroke
boolean
C0027051 (UMLS CUI [1])
C0948008 (UMLS CUI [2])
Peripheral Arterial Disease
Item
2. history of peripheral artery disease
boolean
C1704436 (UMLS CUI [1])
Coronary revascularisation | Carotid revascularisation | Peripheral revascularisation
Item
3. history of revascularization (coronary, carotid, or peripheral artery)
boolean
C0877341 (UMLS CUI [1])
C3495793 (UMLS CUI [2])
C1096418 (UMLS CUI [3])
Coronary Stenosis | Revascularization Absent
Item
4. significant unrevascularized coronary arterial stenosis
boolean
C0242231 (UMLS CUI [1])
C0581603 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Age | Gender | Diabetes Mellitus, Non-Insulin-Dependent | Cardiovascular Disease Absent | Cardiovascular risk factor Quantity
Item
age greater than or equal to 55 years for women or greater than or equal to 50 years for men who have t2dm without established cv disease plus at least one of the following cv risk factors:
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0007222 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0850624 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Hypertensive disease | Therapeutic procedure Hypertensive disease
Item
1. hypertension, or currently receiving therapy for documented hypertension
boolean
C0020538 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
Dyslipidemia | Lipid-lowering therapy Dyslipidemia
Item
2. dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
boolean
C0242339 (UMLS CUI [1])
C0585943 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
Creatinine clearance measurement Creatinine-based formula (CKD-EPI)
Item
3. calculated creatinine clearance greater than or equal to 30 to less than or equal to 60 ml/min per the chronic kidney disease epidemiology collaboration (ckd-epi) equation
boolean
C0373595 (UMLS CUI [1,1])
C2964649 (UMLS CUI [1,2])
High-sensitivity C-reactive protein increased
Item
4. high hscrp
boolean
C1963867 (UMLS CUI [1])
Urine albumin/creatinine ratio measurement
Item
5. urinary albumin-to-creatinine ratio (acr) greater than or equal to 30 ug/mg
boolean
C0455271 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Pre-existing | Non-Insulin-Dependent Diabetes Mellitus Newly Diagnosed
Item
subjects with t2dm may have a pre-existing or new diagnosis of t2dm. a new diagnosis of t2dm (ie, discovered at screening) should be based on the 2013 american diabetes association (ada) guidelines.
boolean
C0011860 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Antidiabetics | Therapeutic procedure Stable Non-Insulin-Dependent Diabetes Mellitus
Item
all t2dm subjects must have an hba[1c] less than 10% at screening. if subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the t2dm treatment regimen must be stable for at least 3 months prior to randomization.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0011860 (UMLS CUI [4,3])
Moderate signs/symptoms Congestive heart failure New York Heart Association Classification | Symptom severe Congestive heart failure New York Heart Association Classification
Item
1. moderate or greater symptoms of congestive cardiac failure (new york heart association [nyha] class iii or iv)
boolean
C3846034 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0436345 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
2. known left ventricular (lv) ejection fraction less than 20%
boolean
C0428772 (UMLS CUI [1])
Moderate signs/symptoms Pulmonary Hypertension | Symptom severe Pulmonary Hypertension
Item
3. moderate or greater symptoms of pulmonary hypertension (ph)
boolean
C3846034 (UMLS CUI [1,1])
C0020542 (UMLS CUI [1,2])
C0436345 (UMLS CUI [2,1])
C0020542 (UMLS CUI [2,2])
Valvular disease | Renal Insufficiency Moderate | Renal Insufficiency Severe | Kidney Failure, Chronic | Creatinine clearance measurement Creatinine-based formula (CKD-EPI) Ideal Body Weight Based
Item
4. known severe valvular disease moderate renal impairment, severe renal impairment, or end stage renal disease (esrd) (calculated creatinine clearance less than 30 ml/min per the ckd-epi equation based on ideal body weight)
boolean
C3258293 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022661 (UMLS CUI [4])
C0373595 (UMLS CUI [5,1])
C2964649 (UMLS CUI [5,2])
C0421272 (UMLS CUI [5,3])
C1705938 (UMLS CUI [5,4])
Hepatic impairment Severe
Item
5. severe hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Weight-Loss Agents | Prescription Drugs | Drugs, Non-Prescription | Plant Preparations
Item
6. use of other products intended for weight loss including prescription drugs, over-the-counter (otc) drugs, and herbal preparations
boolean
C0376606 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0949854 (UMLS CUI [4])
Serotonin Agents Quantity
Item
7. use of more than one other serotonergic drug
boolean
C0242701 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pharmaceutical Preparations At risk Heart valve disease | Cyproheptadine | Amoxapine | Tricyclic Antidepressive Agents | Mirtazapine | Pergolide | Ergotamine | Methysergide | cabergoline
Item
8. use of drugs known to increase the risk for cardiac valvulopathy prior to screening including, but not limited to: cyproheptadine, amoxapine, tcas, mirtazapine, pergolide, ergotamine, methysergide, cabergoline
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0018824 (UMLS CUI [1,3])
C0010620 (UMLS CUI [2])
C0002644 (UMLS CUI [3])
C0003290 (UMLS CUI [4])
C0049506 (UMLS CUI [5])
C0031007 (UMLS CUI [6])
C0014710 (UMLS CUI [7])
C0025842 (UMLS CUI [8])
C0107994 (UMLS CUI [9])
Disease Clinical Significance | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Gastrointestinal Diseases | Kidney Diseases | Mental disorders
Item
9. history or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride | Hypersensitivity Lorcaserin hydrochloride Excipient
Item
10. use of lorcaserin hcl prior to screening or hypersensitivity to lorcaserin hcl or any of the excipients
boolean
C2697942 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2697942 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2697942 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Bariatric Surgery Planned
Item
11. planned bariatric surgery
boolean
C1456587 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
12. females must not be breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])