Date of telephone contact
Item
Date of telephone contact
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Concomitant Medication
Item
Are there any changes in the concomitant medication?
boolean
C2347852 (UMLS CUI [1])
side effects study drug
Item
Did any study-drug side effects occur?
boolean
C0304229 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
regular intake of study medication
Item
Did the patient regularly take the study-drug?
boolean
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study medication intake
Item
If no, please explain:
text
C0013227 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Study drug regimen
Item
Regimen
text
C0237125 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Total dose (mg/d)
integer
C2986497 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Code List
Total dose (mg/d)
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item
Laboratory test performed?
text
C0022885 (UMLS CUI [1])
Code List
Laboratory test performed?
Item
Type of laboratory procedure
integer
C0022885 (UMLS CUI [1])
Code List
Type of laboratory procedure
CL Item
GOT (AST) U/L (1)
CL Item
GPT (ALT) U/L (2)
CL Item
Bilirubin mg/dL (3)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])