Liver chemistry result stopping investigational product: ALT
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? ALT (alanine aminotransferase)
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201836 (UMLS CUI [2])
Liver chemistry result stopping investigational product: AST
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? AST (aspartate aminotransferase)
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201899 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Total bilirubin
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Total bilirubin
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201913 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Alkaline phosphatase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Alkaline phosphatase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201850 (UMLS CUI [2])
Liver chemistry result stopping investigational product: 5' nucleotidase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? 5' nucleotidase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C2700357 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Gammaglutamyltranspeptidase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Gammaglutamyltranspeptidase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0017040 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Other
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Other
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0205394 (UMLS CUI [2])
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Code List
Is the subject age 55 or older?
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Code List
If female, is the subject pregnant?
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)?
text
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
Code List
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)?
Item
Normal results of imaging tests
text
C0086143 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Code List
Normal results of imaging tests
Item
Were any liver biopsies performed?
text
C1518965 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Code List
Were any liver biopsies performed?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C1360419 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
Code List
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Did the subject fast or undergo significant dietary change in the past week?
text
C3671772 (UMLS CUI [1])
C0015663 (UMLS CUI [2])
Code List
Did the subject fast or undergo significant dietary change in the past week?
Item
Occurrence of liver event
integer
C0023884 (UMLS CUI [1,1])
C2697887 (UMLS CUI [1,2])
Code List
Occurrence of liver event
CL Item
Day 1 through Day 10 (1)
Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start date, Investigational Product not applicable
Item
Start date, Investigational Product not applicable
boolean
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End date, Investigational Product not applicable
Item
End date, Investigational Product not applicable
boolean
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item
Relative time unscheduled PK blood sample has been obtained
integer
C0439564 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
Code List
Relative time unscheduled PK blood sample has been obtained
Item
Was a pharmacokinetic blood sample obtained? (24 Hours)
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Code List
Was a pharmacokinetic blood sample obtained? (24 Hours)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of last investigational product dose prior to PK sample
Item
Date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
Time of last investigational product dose prior to PK sample
Item
Time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0699749 (UMLS CUI [1,3])
Code List
Drug related liver disease
CL Item
No Medical Condition (3)
Specific condition
Item
Other Liver disease condition, specific condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
boolean
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
boolean
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status of other liver disease
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Code List
Status of other liver disease
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Code List
Does the subject consume alcohol?
Average alcohol consumption
Item
Average number of units of alcohol consumed per week
float
C0560579 (UMLS CUI [1,1])
C1510992 (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])