Study number
Item
Study number
integer
C2826693 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Nr.:
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID:
integer
C3826248 (UMLS CUI [1])
Visit
Item
Visit
integer
C0545082 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Adverse reaction to study drug
Item
1. Does the subject have a definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure?
boolean
C0559546 (UMLS CUI [1,1])
C0013175 (UMLS CUI [1,2])
Abnormality of organs or blood
Item
2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
boolean
C0243050 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0475182 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Postural hypotension or faints
Item
3. Does the subject have a history of postural hypotension or faints?
boolean
C0020651 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
Gastrointestinal, hepatic or renal disease
Item
4. Does the subject have a history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
Subject's medication
Item
5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
boolean
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C4054723 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
Drugs with effect on CYP1A2
Item
6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
boolean
C1827490 (UMLS CUI [1])
C0919438 (UMLS CUI [2,1])
C0207509 (UMLS CUI [2,2])