Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Laboratory Procedures, Hematology finding, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Laboratory Procedures, Hematology finding, Fasting
Item
Has the subject fasted?
boolean
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
Item
Laboratory Test - Haematology
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
Code List
Laboratory Test - Haematology
CL Item
Platelet count (5)
Laboratory Procedures, Hematology finding, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Laboratory Procedures, Clinical, Chemistry, Fasting
Item
Has the subject fasted?
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
Item
Laboratory Test - Haematology
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Code List
Laboratory Test - Haematology
CL Item
Total protein (6)
CL Item
Total bilirubin (8)
CL Item
Alanine aminotransferase (ALT) (9)
CL Item
Aspartate aminotransferase (AST) (10)
CL Item
Alkaline phosphatase (ALP) (11)
CL Item
Lactate dehydrogenase (LDH) (12)
CL Item
Triglyceride (17)
Laboratory Procedures, Chemistry, Clinical, Result
Item
Result
text
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Urinalysis, Sampling, Date in time, Time
Item
Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Result of dipstick
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of dipstick
Item
Urinalysis (Dipstick) Test
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Code List
Urinalysis (Dipstick) Test
CL Item
Specific gravity (1)
Urinalysis, Urine dipstick test, Test Result
Item
Result
text
C0042014 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement
Item
Was sedimentary microscopy performed?
boolean
C0042014 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
Item
Urinalysis (Microscopy) Test
text
C0042014 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
Code List
Urinalysis (Microscopy) Test
CL Item
Non squamous cells (6)
CL Item
Squamous cells (7)
Urinalysis, Microscopic urinalysis, Urine Sediment Analysis Measurement, Result
Item
Result
text
C0042014 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C2700128 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
Item
Cannabis
text
C0202274 (UMLS CUI [1,1])
C0936079 (UMLS CUI [1,2])
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Urine drug screening, Barbiturates
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Item
Methadone
text
C0202274 (UMLS CUI [1,1])
C0025605 (UMLS CUI [1,2])
Item
Alcohol
text
C0202304 (UMLS CUI [1])
Serum pregnancy test (B-HCG), Sampling, Date in time
Item
Date sample taken
date
C0430060 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C0430060 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL Item
Not applicable (Women with a documented hysterectomy) (3)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
Ritonavir (Morning) (1)
CL Item
Ritonavir (Evening) (2)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental drug, Dosage
Item
Dose
integer
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Unit
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Therapeutic Procedure, Confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Reason and justification
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])