Physical Examination; Assessment date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Hair and skin
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,3])
CL Item
Abnormal (Abnormal)
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Eyes
text
C0031809 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Code List
Ears, Nose and Throat
CL Item
Abnormal (Abnormal)
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Urogenital
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Code List
Musculoskeletal
CL Item
Abnormal (Abnormal)
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
CL Item
Abnormal (Abnormal)
Disease
Item
Diagnosis
text
C0012634 (UMLS CUI [1])
Disease; Current
Item
Current
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Disease; Past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Vital Signs; Date in time
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005823 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Weight
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of the ECG
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Holter Electrocardiography; Start Date
Item
Start date of ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography; Start time
Item
Start time of ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography; End Date
Item
End date of ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography; End time
Item
End time of ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Clinical Chemistry; Sampling; Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Chemistry; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Hematology finding; Sampling; Date in time
Item
Date Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology finding; Time
Item
Actual Time
time
C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis; Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Immunogenicity Study; Blood; relative time
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Immunogenicity Study; Blood; Sampling; Time
Item
Actual Time
time
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sample identification number
Item
integer
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Urine drug screening; Sampling; Date in Time
Item
Date sample taken
date
C0202274 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
PCP
text
C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Code List
Benzodiazepines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cotinine
text
C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Ethanol measurement; Sampling; Date in time
Item
Date sample taken
date
C0202304 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
HIV Seropositivity; hepatitis b serology; hepatitis C serology test; Specimen collection date
Item
Date sample taken
text
C0019699 (UMLS CUI [1,1])
C0744837 (UMLS CUI [1,2])
C0850489 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
Item
HIV antibody
text
C0019683 (UMLS CUI [1])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Code List
Hepatitis B surface antigen
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1])
Code List
Hepatitis C antibody
CL Item
Positive (Positive)
CL Item
Negative (Negative)