Renal function Stable | Serum creatinine measurement Quantity | Difference Measurements Percentage | Creatinine clearance measurement Quantity
Item
stable renal function defined as <20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. crcl value at screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
boolean
C0232804 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1705242 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0373595 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Body mass index | Body Weight
Item
body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Protocol Compliance
Item
subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Hormonal contraception Excluded
Item
pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C2985296 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
Myocardial Infarction | Angina, Unstable | Coronary revascularisation | Cerebrovascular accident | Transient Ischemic Attack
Item
subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (tia).
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0877341 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
Heart failure Severe New York Heart Association Classification
Item
subjects with severe heart failure (new york heart association functional class iv) at screening.
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Kidney Disease
Item
subjects with acute renal disease.
boolean
C0022658 (UMLS CUI [1])