Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (sitting) - Day 37 - 42, Follow up
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Vital Signs Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Electrocardiogram (Day 37)
C1623258 (UMLS CUI-1)
Date ECG Performed
Item
Date ECG Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time ECG Performed
Item
Time ECG Performed
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1])
QTcF Interval
Item
QTcF Interval
integer
C1882513 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (UMLS CUI [1])
Normal Sinus Rhythm?
Item
Normal Sinus Rhythm?
boolean
C0232202 (UMLS CUI [1])
Item
Overall interpretation of ECG
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
Code List
Overall interpretation of ECG
CL Item
Abnormal; Clinically Significant (2)
CL Item
Abnormal; Not Clinically Significant (3)
If abnormal, please specify:
Item
If abnormal, please specify:
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item Group
Central Laboratory - Haematology (Day 37)
C1880016 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Was the laboratory sample collected? (Haematology)
Item
Was the laboratory sample collected? (Haematology)
boolean
C0005834 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Sample Date (Haematology)
Item
Sample Date (Haematology)
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Sample Time (Haematology)
Item
Sample Time (Haematology)
time
C0005834 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Comment (Haematology)
Item
Comment (Haematology)
text
C0947611 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Central Laboratory - Chemistry (Day 37)
C1880016 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Was the laboratory sample collected? (Chemistry)
Item
Was the laboratory sample collected? (Chemistry)
boolean
C0005834 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Sample Date (Chemistry)
Item
Sample Date (Chemistry)
date
C1302413 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Sample Time (Chemistry)
Item
Sample Time (Chemistry)
time
C0005834 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Comment (Chemistry)
Item
Comment (Chemistry)
text
C0947611 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Central Laboratory - UA/UDS/Urine HCG/ Urine Chem (Day 37)
C1880016 (UMLS CUI-1)
C0864414 (UMLS CUI-2)
C0430056 (UMLS CUI-3)
Was the laboratory sample collected? (Urine)
Item
Was the laboratory sample collected? (Urine)
boolean
C0005834 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
Sample Date (Urine)
Item
Sample Date (Urine)
date
C1302413 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
Sample Time (Urine)
Item
Sample Time (Urine)
time
C0005834 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Comment (Urine)
Item
Comment (Urine)
text
C0947611 (UMLS CUI [1])
C0042036 (UMLS CUI [2])
Item Group
Study Drug Administration (80 mg Simvastatin) - Day 38
C0013153 (UMLS CUI-1)
C0074554 (UMLS CUI-2)
Was the dose administered?
Item
Was the dose administered?
boolean
C3174092 (UMLS CUI [1])
C3469597 (UMLS CUI [2])
Dose Date
Item
Dose Date
date
C0178602 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Dose Time
Item
Dose Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item
Site of injection
integer
C2700396 (UMLS CUI [1])
Code List
Site of injection
CL Item
Right Abdomen (1)
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 38
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Albiglutide) - Day 38
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C2607479 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 39
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 40
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 41
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Pharmacokinetic Blood Collection (Simvastatin) - Day 42
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])