Liver function | Liver parameters Normal Range
Item
subjects with normal hepatic function and liver parameters within normal range
boolean
C0232741 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,3])
Hepatic impairment Stable Child-Pugh Classification
Item
subjects with stable hepatic impairment classified as child-pugh grade a, b or c
boolean
C0948807 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
Body mass index
Item
body mass index between 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Transplantation of liver
Item
liver transplanted subjects
boolean
C0023911 (UMLS CUI [1])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Hepatic Insufficiency Signs
Item
signs of acute liver insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
HIV antibody positive
Item
positive hiv (human immunodeficiency virus) 1+2 antibodies
boolean
C0920548 (UMLS CUI [1])
Malignant Neoplasm | Disease Clinical Significance | Condition Associated with Hepatic impairment
Item
cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0948807 (UMLS CUI [3,3])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Tobacco Equivalent
Item
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0040329 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink
Item
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0005329 (UMLS CUI [1,3])
C0066447 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
C0066447 (UMLS CUI [2,4])
C0009830 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0009237 (UMLS CUI [3,3])
C0009830 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
C0039400 (UMLS CUI [4,3])
C0009830 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
C3489624 (UMLS CUI [5,3])
C0009830 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
C0452444 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0442802 (UMLS CUI [7,2])
C0452243 (UMLS CUI [7,3])