Vital Signs - Date
Item
Vital Signs - Date
date
C2826644 (UMLS CUI [1])
Planned Relative Time - Vital Signs
Item
Planned Relative Time - Vital Signs
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Actual Time
Item
Actual Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned relative Time - ECG
Item
Planned relative Time - ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12-Lead ECG - Heart Rate
Item
12-Lead ECG - Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Haematology - Date and time sample taken
Item
Haematology - Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Has the subject fasted
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Platelet Count
Item
Platelet Count
float
C0005821 (UMLS CUI [1])
RBC Count
Item
RBC Count
float
C0014772 (UMLS CUI [1])
WBC Count (absolute)
Item
WBC Count (absolute)
float
C0023508 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
Reticulocyte Count
Item
Reticulocyte Count
float
C0206161 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
MCV
Item
MCV
float
C1948043 (UMLS CUI [1])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Clinical Chemistry - Date and time sample taken
Item
Clinical Chemistry - Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Has the subject fasted
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Glucose, fasting
Item
Glucose, fasting
float
C0583513 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Total CO2
Item
Total CO2
float
C0860709 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1])
AP
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Direct bilirubin
Item
Direct bilirubin
float
C0201916 (UMLS CUI [1])
Uric Acid
Item
Uric Acid
float
C0041980 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Urinalysis (Dipstick) Test - Specific gravity
Item
Urinalysis (Dipstick) Test - Specific gravity
text
C0430383 (UMLS CUI [1])
Urinalysis (Dipstick) Test - pH
Item
Urinalysis (Dipstick) Test - pH
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Glucose
Item
Urinalysis (Dipstick) Test - Glucose
text
C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Protein
Item
Urinalysis (Dipstick) Test - Protein
text
C0262923 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Blood
Item
Urinalysis (Dipstick) Test - Blood
text
C0202514 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Ketones
Item
Urinalysis (Dipstick) Test - Ketones
text
C1991100 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C2700128 (UMLS CUI [1])
Urinalysis (Microscopy) Test - Cellular casts
Item
Urinalysis (Microscopy) Test - Cellular casts
text
C2699157 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - Granular casts
Item
Urinalysis (Microscopy) Test - Granular casts
text
C2697521 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
Item
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
text
C1254537 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0034375 (UMLS CUI [1,3])
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
Item
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
text
C1254537 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
Urinalysis (Microscopy) Test - RBC
Item
Urinalysis (Microscopy) Test - RBC
text
C0014772 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - WBC
Item
Urinalysis (Microscopy) Test - WBC
text
C0023508 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Record randomisation number.
Item
Record randomisation number.
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of randomisation
Item
Time of randomisation
time
C0034656 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Investigational Product - Date of Dose
Item
Investigational Product - Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Investigational Product - Time of Dose
Item
Investigational Product - Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Investigational Product - Dose
Item
Investigational Product - Dose
float
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Investigational Product - Units
Item
Investigational Product - Units
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
If the subject did not receive the correct treatment, record reasons
Item
If the subject did not receive the correct treatment, record reasons.
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of PET Scan
Item
Date of PET Scan
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PET Scan Examination Number
Item
PET Scan Examination Number
text
C0032743 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Name of Tracer
Item
Name of Tracer
text
C1522485 (UMLS CUI [1])
Radiochemical Purity at Release
Item
Radiochemical Purity at Release
integer
C0182638 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
Radiochemical purity time at release
Item
Radiochemical purity time at release
time
C0182638 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Mass of Tracer Administered
Item
Mass of Tracer Administered
float
C1522485 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Volume to be Administered (inc diluent)
Item
Volume to be Administered (inc diluent)
float
C0009924 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Bolus Activity lnjected
Item
Bolus Activity lnjected
float
C1511237 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Start Time of Bolus Injection
Item
Start Time of Bolus Injection
time
C1511237 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Duration of Bolus Injection
Item
Duration of Bolus Injection
durationDatetime
C1511237 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Constant Infusion Activity Concentration (at start of infusion)
Item
Constant Infusion Activity Concentration (at start of infusion)
float
C0574032 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Start Time of Constant Infusion
Item
Start Time of Constant Infusion
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Time of Constant Infusion
Item
End Time of Constant Infusion
time
C0574032 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Volume of Constant Infusion Administered
Item
Volume of Constant Infusion Administered
float
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Has an fMRl Scan been carried out
Item
Has an fMRl Scan been carried out?
boolean
C0376335 (UMLS CUI [1])
If an fMRl Scan has been carried out, record date and time
Item
If an fMRl Scan has been carried out, record date and time
datetime
C0376335 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
fMRI - Comments
Item
fMRI - Comments
text
C0376335 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of PET Scan
Item
Date of PET Scan
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
PET Scan Examination Number
Item
PET Scan Examination Number
text
C0032743 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Name of Tracer
Item
Name of Tracer
text
C1522485 (UMLS CUI [1])
Radiochemical Purity at Release
Item
Radiochemical Purity at Release
integer
C0182638 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
Radiochemical purity time at release
Item
Radiochemical purity time at release
time
C0182638 (UMLS CUI [1,1])
C0678739 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Mass of Tracer Administered
Item
Mass of Tracer Administered
float
C1522485 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Volume to be Administered (inc diluent)
Item
Volume to be Administered (inc diluent)
float
C0009924 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Bolus Activity lnjected
Item
Bolus Activity lnjected
float
C1511237 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Start Time of Bolus Injection
Item
Start Time of Bolus Injection
time
C1511237 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Duration of Bolus Injection
Item
Duration of Bolus Injection
durationDatetime
C1511237 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Constant Infusion Activity Concentration (at start of infusion)
Item
Constant Infusion Activity Concentration (at start of infusion)
float
C0574032 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Start Time of Constant Infusion
Item
Start Time of Constant Infusion
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Time of Constant Infusion
Item
End Time of Constant Infusion
time
C0574032 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Volume of Constant Infusion Administered
Item
Volume of Constant Infusion Administered
float
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Pharmacokinetics - Planned Relative Time
Item
Pharmacokinetics - Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Pharmacokinetics - Date Sample Taken
Item
Pharmacokinetics - Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Pharmacokinetics - Actual Time
Item
Pharmacokinetics - Actual Time
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Pharmacokinetics - Sample taken
integer
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
Code List
Pharmacokinetics - Sample taken
Pharmacokinetics - Sample Number
Item
Pharmacokinetics - Sample Number
integer
C0031328 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Item
Pharmacokinetics - Sample missed or lost
integer
C0031328 (UMLS CUI [1])
C3845781 (UMLS CUI [2])
C0005834 (UMLS CUI [3,1])
C1705492 (UMLS CUI [3,2])
Code List
Pharmacokinetics - Sample missed or lost
CL Item
Sample missed or lost (1)
Haematology - Date and time sample taken
Item
Haematology - Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Has the subject fasted
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Platelet Count
Item
Platelet Count
float
C0005821 (UMLS CUI [1])
RBC Count
Item
RBC Count
float
C0014772 (UMLS CUI [1])
WBC Count (absolute)
Item
WBC Count (absolute)
float
C0023508 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
Reticulocyte Count
Item
Reticulocyte Count
float
C0206161 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
MCV
Item
MCV
float
C1948043 (UMLS CUI [1])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Clinical Chemistry - Date and time sample taken
Item
Clinical Chemistry - Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Has the subject fasted
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Glucose, fasting
Item
Glucose, fasting
float
C0583513 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
Total CO2
Item
Total CO2
float
C0860709 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Direct bilirubin
Item
Direct bilirubin
float
C0201916 (UMLS CUI [1])
Uric Acid
Item
Uric Acid
float
C0041980 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Urinalysis (Dipstick) Test - Specic gravity
Item
Urinalysis (Dipstick) Test - Specic gravity
text
C0430383 (UMLS CUI [1])
Urinalysis (Dipstick) Test - pH
Item
Urinalysis (Dipstick) Test - pH
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Glucose
Item
Urinalysis (Dipstick) Test - Glucose
text
C0004076 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Protein
Item
Urinalysis (Dipstick) Test - Protein
text
C0262923 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Blood
Item
Urinalysis (Dipstick) Test - Blood
text
C0202514 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test - Ketones
Item
Urinalysis (Dipstick) Test - Ketones
text
C1991100 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Was sedimentary microscopy performed?
Item
Was sedimentary microscopy performed?
boolean
C2700128 (UMLS CUI [1])
Urinalysis (Microscopy) Test - Cellular casts
Item
Urinalysis (Microscopy) Test - Cellular casts
text
C2699157 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - Granular casts
Item
Urinalysis (Microscopy) Test - Granular casts
text
C2697521 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
Item
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
text
C1254537 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0034375 (UMLS CUI [1,3])
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
Item
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
text
C1254537 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
C0392762 (UMLS CUI [1,3])
Urinalysis (Microscopy) Test - RBC
Item
Urinalysis (Microscopy) Test - RBC
text
C0014772 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Urinalysis (Microscopy) Test - WBC
Item
Urinalysis (Microscopy) Test - WBC
text
C0023508 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])