Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe | Liver Cirrhosis Due to Parenchymal liver disease | Child-Pugh Classification | Medical History | Physical Examination | Ultrasonography of liver | CT scan | Magnetic Resonance Imaging | Biopsy of liver
Item
only for subjects with hepatic impairment (mild, moderate and severe): a diagnosis of cirrhosis due to parenchymal liver disease, classified as child-pugh grade a,b or c as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (ct) scan, magnetic resonance imaging (mri), and/or liver biopsy
boolean
C0948807 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0745745 (UMLS CUI [4,3])
C4050412 (UMLS CUI [5])
C0262926 (UMLS CUI [6])
C0031809 (UMLS CUI [7])
C0412534 (UMLS CUI [8])
C0040405 (UMLS CUI [9])
C0024485 (UMLS CUI [10])
C0193388 (UMLS CUI [11])
Normal liver function | General health good | Physical Examination | Medical History | Electrocardiography | Vital signs | Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis
Item
only for subjects with normal hepatic function: subjects who are judged to be in good general health based on physical examination, medical history, ecg, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator
boolean
C1848676 (UMLS CUI [1])
C1277245 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0428132 (UMLS CUI [7])
C0005790 (UMLS CUI [8])
C0018941 (UMLS CUI [9])
C0042014 (UMLS CUI [10])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | White Coat Hypertension Suspected
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg). if white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0262534 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language Barrier Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Protocol Compliance Unwilling | Language Barrier Excludes Protocol Compliance
Item
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0237167 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C1306341 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0237167 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Blood Donation | Plasma Donation | Blood Donation Excessive | Plasma Donation Excessive | Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount
Item
donation of any blood or plasma in the past month or in excess of 400 ml within the 3 months preceding screening, or surgery or trauma with more than 400 ml blood loss within the 3 months preceding screening
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
C0442802 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C3163616 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3714660 (UMLS CUI [6,1])
C3163616 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])