Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs - Prior to Infusion
C0518766 (UMLS CUI-1)
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver Events - Date of assessment
Item
Liver Events - Date of assessment
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5` nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (OT)
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0436427 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
Item
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Start Date Investigational Product - During treatment period
Item
Start Date Investigational Product - During treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Item
Start Date Investigational Product - During treatment period
integer
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Start Date Investigational Product - During treatment period
Code List
Start Date Investigational Product - During treatment period
CL Item
Not applicable (98)
Stop Date Investigational Product - During treatment period
Item
Stop Date Investigational Product - During treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Item
Stop Date Investigational Product - During treatment period
integer
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Stop Date Investigational Product - During treatment period
Code List
Stop Date Investigational Product - During treatment period
CL Item
Not applicable (98)
Start Date Investigational Product - After treatment period
Item
Start Date Investigational Product - After treatment period
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Item
Start Date Investigational Product - After treatment period
integer
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Start Date Investigational Product - After treatment period
Code List
Start Date Investigational Product - After treatment period
CL Item
Not applicable (98)
Stop Date Investigational Product - After treatment period
Item
Stop Date Investigational Product - After treatment period
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Item
Stop Date Investigational Product - After treatment period
integer
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
Stop Date Investigational Product - After treatment period
Code List
Stop Date Investigational Product - After treatment period
CL Item
Not applicable (98)
Item Group
Pharmacokinetics (Liver)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Date and time of last investigational product dose prior to PK sample
Item
Date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C1277698 (UMLS CUI [3,1])
C0031327 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Item Group
Medical Conditions (Liver)
C0012634 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Medical Condition
integer
C0012634 (UMLS CUI [1])
Medical Condition
Code List
Medical Condition
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug related liver disease conditions
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease status
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Drug related liver disease status
Code List
Drug related liver disease status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Other Liver disease conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other Liver disease conditions - Sequence Number
Item
Other Liver disease conditions - Sequence Number
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Other Liver disease conditions - Specific Condition
Item
Other Liver disease conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Other Liver disease conditions - Modified Term
Item
Other Liver disease conditions - Modified Term
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
Other Liver disease conditions - MedDRA Synonym
Item
Other Liver disease conditions - MedDRA Synonym
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
Other Liver disease conditions - MedDRA lower level term code
Item
Other Liver disease conditions - MedDRA lower level term code
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,3])
Other Liver disease conditions - Failed coding
Item
Other Liver disease conditions - Failed coding
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Item
Other Liver disease conditions - Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Other Liver disease conditions - Status
Code List
Other Liver disease conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Other medical condition
integer
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other medical condition
Code List
Other medical condition
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Arthritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Other medical condition
integer
C3176928 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other medical condition
Code List
Other medical condition
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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