Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Absent | Amenorrhea Duration | Tubal Ligation | Total hysterectomy | Bilateral oophorectomy
Item
males are allowed and females of childbearing potential if adequate contraception is used. females of non-childbearing potential should be amenorrheal for at least 2 years, or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0002453 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0520483 (UMLS CUI [5])
C0677962 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
Renal Insufficiency Severe | Consistent with Chronic Kidney Failure Symptoms | General health good Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Laboratory Procedures | Comorbidity Under Control Stable
Item
for participants with severe renal impairment: consistent with the disease process of chronic renal failure and associated symptoms, otherwise judged to be in good health in the opinion of the investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiogram (ecg), vital signs, and screening laboratory tests), with any concomitant medical conditions under stable medical control
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332290 (UMLS CUI [2,1])
C0022661 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C1277245 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0031809 (UMLS CUI [4])
C0262926 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
C0518766 (UMLS CUI [7])
C0022885 (UMLS CUI [8])
C0009488 (UMLS CUI [9,1])
C2911690 (UMLS CUI [9,2])
C0205360 (UMLS CUI [9,3])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
for participants with severe renal impairment: creatinine clearance < 30 ml/min (cockcroft-gault)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Healthy Control | Abnormality Absent Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Blood Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis
Item
for healthy controls: healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ecg, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
boolean
C2986479 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0005767 (UMLS CUI [7,1])
C0428132 (UMLS CUI [7,2])
C0005790 (UMLS CUI [8])
C0018941 (UMLS CUI [9])
C0042014 (UMLS CUI [10])
Illness Interferes with Research results | Illness Investigational New Drugs At risk | Diabetes Mellitus | Drug Allergy | Food Allergy
Item
a history of any illness (unrelated to renal impairment, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study medication to the participant. this may include but is not limited to: diabetes mellitus, history of relevant drug or food allergies
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0013182 (UMLS CUI [4])
C0016470 (UMLS CUI [5])
Cardiovascular Disease | CNS disorder
Item
history of cardiovascular or central nervous system disease
boolean
C0007222 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
Pathology Clinical Significance | Chronic disease of skin | Mental disorders
Item
history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
boolean
C0677042 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1290009 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Renal Insufficiency Severe | Kidney Transplantation | Renal carcinoma
Item
for subjects with severe renal impairment: history of renal transplant or renal carcinoma. participants with a history of renal carcinoma who have been cancer free for at least 5 years may be included
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2])
C1378703 (UMLS CUI [3])
Renal Insufficiency Severe | Chronic Kidney Failure Requirement Dialysis
Item
for participants with severe renal impairment: participants with end stage renal disease (esrd) requiring dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Healthy Control | Prescription Drugs | Non-Prescription Drugs Regular
Item
for healthy controls: current use of prescription medication and regular treatment with over-the-counter medications
boolean
C2986479 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0013231 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])