Liver Dysfunction or Failure by Clinical Classification Adverse Event, Serious Adverse Event
Item
Is this liver event a serious adverse event?
boolean
C1556667 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Email, last, Medical Monitor, Date in time, Time
Item
Last Email Sent to Medical Monitor
datetime
C0013849 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, first, Medical Monitor, Date in time, Time
Item
Initial Email Sent to Medical Monitor
datetime
C0013849 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, Last, Clinical Trial Safety Documentation, Date in time, Time
Item
Last Email Sent to GCSP
datetime
C0013849 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Email, First, Clinical Trial Safety Documentation, Date in time, Time
Item
Initial Email Sent to GCSP
datetime
C0013849 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Liver Dysfunction or Failure by Clinical Classification Adverse Event, Non-serious Adverse Event, Date in time, Time
Item
Changed to Non Serious on
datetime
C1556667 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption criteria?
text
C0232741 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/interruption 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)
Age
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])
Code List
If female, is the subject pregnant?
CL Item
Not applicable (Not applicable)
Liver, Diagnostic Imaging; Hepatobiliary System, Diagnostic Imaging
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
C0023884 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1711359 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Liver, Diagnostic Imaging, Results; Hepatobiliary System, Diagnostic Imaging, Results
Item
If Yes, were the results normal?
boolean
C0023884 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1711359 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
Biopsy of liver
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbal medicine; Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use
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])
Fasting, Change in Diet
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
Item
When did the liver event occur?
text
C1556667 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
When did the liver event occur?
CL Item
During the treatment period (During the treatment period)
CL Item
After the treatment period (After the treatment period)
Experimental Drug, Start Date
Item
Start Date Investigational Products
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Experimental Drug, End Date
Item
End Date Investigational Products
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])