Alcohol abuse
Item
7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
boolean
C0038586 (UMLS CUI [1])
Other clinical trial, blood donation or blood loss
Item
8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
boolean
C0679823 (UMLS CUI [1,1])
C1516648 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
C3163616 (UMLS CUI [3])
Hepatitis B, C or HIV antibodies
Item
9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
boolean
C2711110 (UMLS CUI [1])
C0019683 (UMLS CUI [2])
Pregnant or breast-feeding
Item
10. Is the subject pregnant and/or breast-feeding?
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
No contraception
Item
11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
boolean
C3831118 (UMLS CUI [1,1])
C0445107 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Positive pregnancy test
Item
12. Is the subject a female with positive urine/serum pregnancy test result at screening?
boolean
C0240802 (UMLS CUI [1])