ID

44904

Beskrivning

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Nyckelord

Versioner (4)
  1. 2019-06-11 2019-06-11 -
  2. 2022-04-01 2022-04-01 - Martin Dugas
  3. 2022-04-01 2022-04-01 - Martin Dugas
  4. 2022-04-06 2022-04-06 - Martin Dugas
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 april 2022

DOI

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Licens

Creative Commons BY-NC 4.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503

Engelsk

Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Date
Beskrivning

Vital Signs - Date

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time - Vital Signs
Beskrivning

Planned Relative Time - Vital Signs

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure Semi-supine
Beskrivning

Systolic Blood Pressure Semi-supine

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beskrivning

Diastolic Blood Pressure Semi-supine

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beskrivning

ECG Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned relative Time - ECG
Beskrivning

Planned relative Time - ECG

Datatyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Beskrivning

Start Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
12-Lead ECG - Heart Rate
Beskrivning

12-Lead ECG - Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Beskrivning

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Laboratory Results Data (Haematology) - Pre-Dose
Beskrivning

Laboratory Results Data (Haematology) - Pre-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
UMLS CUI-3
C0439565
Haematology - Date and time sample taken
Beskrivning

Haematology - Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Has the subject fasted?
Beskrivning

Has the subject fasted

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Platelet Count
Beskrivning

Platelet Count

Datatyp

float

Alias
UMLS CUI [1]
C0005821
RBC Count
Beskrivning

RBC Count

Datatyp

float

Alias
UMLS CUI [1]
C0014772
WBC Count (absolute)
Beskrivning

WBC Count (absolute)

Datatyp

float

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205344
Reticulocyte Count
Beskrivning

Reticulocyte Count

Datatyp

float

Alias
UMLS CUI [1]
C0206161
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Måttenheter
  • g/dl
Alias
UMLS CUI [1]
C0019046
g/dl
MCV
Beskrivning

MCV

Datatyp

float

Alias
UMLS CUI [1]
C1948043
MCHC
Beskrivning

MCHC

Datatyp

float

Alias
UMLS CUI [1]
C0474535
Neutrophils
Beskrivning

Neutrophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200635
%
Monocytes
Beskrivning

Monocytes

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200637
%
Eosinophils
Beskrivning

Eosinophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophils
Beskrivning

Basophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200641
%
Laboratory Results Data (Clinical Chemistry) - Pre-Dose
Beskrivning

Laboratory Results Data (Clinical Chemistry) - Pre-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439565
Clinical Chemistry - Date and time sample taken
Beskrivning

Clinical Chemistry - Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Has the subject fasted?
Beskrivning

Has the subject fasted

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
BUN
Beskrivning

BUN

Datatyp

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Beskrivning

Creatinine

Datatyp

float

Måttenheter
  • mg/dl
Alias
UMLS CUI [1]
C0201976
mg/dl
Glucose, fasting
Beskrivning

Glucose, fasting

Datatyp

float

Alias
UMLS CUI [1]
C0583513
Sodium
Beskrivning

Sodium

Datatyp

float

Måttenheter
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Potassium
Beskrivning

Potassium

Datatyp

float

Måttenheter
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Chloride
Beskrivning

Chloride

Datatyp

float

Alias
UMLS CUI [1]
C0201952
Total CO2
Beskrivning

Total CO2

Datatyp

float

Alias
UMLS CUI [1]
C0860709
Calcium
Beskrivning

Calcium

Datatyp

float

Alias
UMLS CUI [1]
C0201925
AST (SGOT)
Beskrivning

AST

Datatyp

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Beskrivning

ALT

Datatyp

float

Alias
UMLS CUI [1]
C0201836
GGT
Beskrivning

GGT

Datatyp

float

Alias
UMLS CUI [1]
C0202035
Alkaline phosphatase
Beskrivning

AP

Datatyp

float

Alias
UMLS CUI [1]
C0201850
Total bilirubin
Beskrivning

Total bilirubin

Datatyp

float

Alias
UMLS CUI [1]
C0201913
Direct bilirubin
Beskrivning

Direct bilirubin

Datatyp

float

Alias
UMLS CUI [1]
C0201916
Uric Acid
Beskrivning

Uric Acid

Datatyp

float

Alias
UMLS CUI [1]
C0041980
Albumin
Beskrivning

Albumin

Datatyp

float

Alias
UMLS CUI [1]
C0201838
Total Protein
Beskrivning

Total Protein

Datatyp

float

Alias
UMLS CUI [1]
C0555903
Urinalysis - Pre-Dose
Beskrivning

Urinalysis - Pre-Dose

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439565
Urinalysis Date and time sample taken
Beskrivning

Urinalysis Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis (Dipstick) Test - Specific gravity
Beskrivning

Urinalysis (Dipstick) Test - Specific gravity

Datatyp

text

Alias
UMLS CUI [1]
C0430383
Urinalysis (Dipstick) Test - pH
Beskrivning

Urinalysis (Dipstick) Test - pH

Datatyp

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Glucose
Beskrivning

Urinalysis (Dipstick) Test - Glucose

Datatyp

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Protein
Beskrivning

Urinalysis (Dipstick) Test - Protein

Datatyp

text

Alias
UMLS CUI [1,1]
C0262923
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Blood
Beskrivning

Urinalysis (Dipstick) Test - Blood

Datatyp

text

Alias
UMLS CUI [1,1]
C0202514
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Ketones
Beskrivning

Urinalysis (Dipstick) Test - Ketones

Datatyp

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0430370
Was sedimentary microscopy performed?
Beskrivning

Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Datatyp

boolean

Alias
UMLS CUI [1]
C2700128
Urinalysis (Microscopy) Test - Cellular casts
Beskrivning

Urinalysis (Microscopy) Test - Cellular casts

Datatyp

text

Alias
UMLS CUI [1,1]
C2699157
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - Granular casts
Beskrivning

Urinalysis (Microscopy) Test - Granular casts

Datatyp

text

Alias
UMLS CUI [1,1]
C2697521
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
Beskrivning

Urinalysis (Microscopy) Test - Hyaline casts (qualitative)

Datatyp

text

Alias
UMLS CUI [1,1]
C1254537
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C0034375
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
Beskrivning

Urinalysis (Microscopy) Test - Hyaline casts (quantitative)

Datatyp

text

Alias
UMLS CUI [1,1]
C1254537
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C0392762
Urinalysis (Microscopy) Test - RBC
Beskrivning

Urinalysis (Microscopy) Test - RBC

Datatyp

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - WBC
Beskrivning

Urinalysis (Microscopy) Test - WBC

Datatyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0430397
Randomisation Number
Beskrivning

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Beskrivning

Record randomisation number.

Datatyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Beskrivning

Date of randomisation

Datatyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Time of randomisation
Beskrivning

Time of randomisation

Datatyp

time

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0040223
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product - Date of Dose
Beskrivning

Investigational Product - Date of Dose

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Investigational Product - Time of Dose
Beskrivning

Investigational Product - Time of Dose

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Investigational Product - Dose
Beskrivning

Investigational Product - Dose

Datatyp

float

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Investigational Product - Units
Beskrivning

Investigational Product - Units

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519795
Treatment Confirmation
Beskrivning

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If the subject did not receive the correct treatment, record reasons.
Beskrivning

If the subject did not receive the correct treatment, record reasons

Datatyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0392360
PET Scan (2)
Beskrivning

PET Scan (2)

Alias
UMLS CUI-1
C0032743
Date of PET Scan
Beskrivning

Date of PET Scan

Datatyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
PET Scan Examination Number
Beskrivning

PET Scan Examination Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
Name of Tracer
Beskrivning

Name of Tracer

Datatyp

text

Alias
UMLS CUI [1]
C1522485
Radiochemical Purity at Release
Beskrivning

Radiochemical Purity at Release

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0678739
%
Radiochemical purity time at release
Beskrivning

Radiochemical purity time at release

Datatyp

time

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0678739
UMLS CUI [1,3]
C0040223
Mass of Tracer Administered
Beskrivning

Mass of Tracer Administered

Datatyp

float

Måttenheter
  • ug
Alias
UMLS CUI [1,1]
C1522485
UMLS CUI [1,2]
C0178602
ug
Volume to be Administered (inc diluent)
Beskrivning

Volume to be Administered (inc diluent)

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0449468
mL
Bolus Activity lnjected
Beskrivning

Bolus Activity lnjected

Datatyp

float

Måttenheter
  • MBq/mL
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Start Time of Bolus Injection
Beskrivning

Start Time of Bolus Injection

Datatyp

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1301880
Duration of Bolus Injection
Beskrivning

Duration of Bolus Injection

Datatyp

durationDatetime

Måttenheter
  • min
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0449238
min
Constant Infusion Activity Concentration (at start of infusion)
Beskrivning

Constant Infusion Activity Concentration (at start of infusion)

Datatyp

float

Måttenheter
  • MBq/mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Start Time of Constant Infusion
Beskrivning

Start Time of Constant Infusion

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
End Time of Constant Infusion
Beskrivning

End Time of Constant Infusion

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1522314
Volume of Constant Infusion Administered
Beskrivning

Volume of Constant Infusion Administered

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
mL
fMRI Scan - Post-PET Scan
Beskrivning

fMRI Scan - Post-PET Scan

Alias
UMLS CUI-1
C0376335
UMLS CUI-2
C0032743
UMLS CUI-3
C0687676
Has an fMRl Scan been carried out?
Beskrivning

Has an fMRl Scan been carried out

Datatyp

boolean

Alias
UMLS CUI [1]
C0376335
If an fMRl Scan has been carried out, record date and time
Beskrivning

If an fMRl Scan has been carried out, record date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C1264639
fMRI - Comments
Beskrivning

fMRI - Comments

Datatyp

text

Alias
UMLS CUI [1,1]
C0376335
UMLS CUI [1,2]
C0947611
PET Scan (3)
Beskrivning

PET Scan (3)

Alias
UMLS CUI-1
C0032743
Date of PET Scan
Beskrivning

Date of PET Scan

Datatyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
PET Scan Examination Number
Beskrivning

PET Scan Examination Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
Name of Tracer
Beskrivning

Name of Tracer

Datatyp

text

Alias
UMLS CUI [1]
C1522485
Radiochemical Purity at Release
Beskrivning

Radiochemical Purity at Release

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0678739
%
Radiochemical purity time at release
Beskrivning

Radiochemical purity time at release

Datatyp

time

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0678739
UMLS CUI [1,3]
C0040223
Mass of Tracer Administered
Beskrivning

Mass of Tracer Administered

Datatyp

float

Måttenheter
  • ug
Alias
UMLS CUI [1,1]
C1522485
UMLS CUI [1,2]
C0178602
ug
Volume to be Administered (inc diluent)
Beskrivning

Volume to be Administered (inc diluent)

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0449468
mL
Bolus Activity lnjected
Beskrivning

Bolus Activity lnjected

Datatyp

float

Måttenheter
  • MBq/mL
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Start Time of Bolus Injection
Beskrivning

Start Time of Bolus Injection

Datatyp

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1301880
Duration of Bolus Injection
Beskrivning

Duration of Bolus Injection

Datatyp

durationDatetime

Måttenheter
  • min
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0449238
min
Constant Infusion Activity Concentration (at start of infusion)
Beskrivning

Constant Infusion Activity Concentration (at start of infusion)

Datatyp

float

Måttenheter
  • MBq/mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Start Time of Constant Infusion
Beskrivning

Start Time of Constant Infusion

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
End Time of Constant Infusion
Beskrivning

End Time of Constant Infusion

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1522314
Volume of Constant Infusion Administered
Beskrivning

Volume of Constant Infusion Administered

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
mL
Pharmacokinetics - Blood
Beskrivning

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Pharmacokinetics - Planned Relative Time
Beskrivning

Pharmacokinetics - Planned Relative Time

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Pharmacokinetics - Date Sample Taken
Beskrivning

Pharmacokinetics - Date Sample Taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1302413
Pharmacokinetics - Actual Time
Beskrivning

Pharmacokinetics - Actual Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Pharmacokinetics - Sample taken
Beskrivning

Check if sample taken.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Pharmacokinetics - Sample Number
Beskrivning

Pharmacokinetics - Sample Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1299222
Pharmacokinetics - Sample missed or lost
Beskrivning

Pharmacokinetics - Sample missed or lost

Datatyp

integer

Alias
UMLS CUI [1]
C0031328
UMLS CUI [2]
C3845781
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C1705492
Laboratory Results Data (Haematology) - 24hrs Post-Dose
Beskrivning

Laboratory Results Data (Haematology) - 24hrs Post-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
UMLS CUI-3
C0439568
Haematology - Date and time sample taken
Beskrivning

Haematology - Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Has the subject fasted?
Beskrivning

Has the subject fasted

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Platelet Count
Beskrivning

Platelet Count

Datatyp

float

Alias
UMLS CUI [1]
C0005821
RBC Count
Beskrivning

RBC Count

Datatyp

float

Alias
UMLS CUI [1]
C0014772
WBC Count (absolute)
Beskrivning

WBC Count (absolute)

Datatyp

float

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205344
Reticulocyte Count
Beskrivning

Reticulocyte Count

Datatyp

float

Alias
UMLS CUI [1]
C0206161
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Alias
UMLS CUI [1]
C0019046
MCV
Beskrivning

MCV

Datatyp

float

Alias
UMLS CUI [1]
C1948043
MCHC
Beskrivning

MCHC

Datatyp

float

Alias
UMLS CUI [1]
C0474535
Neutrophils
Beskrivning

Neutrophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200633
%
Lymphocytes
Beskrivning

Lymphocytes

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200635
%
Monocytes
Beskrivning

Monocytes

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200637
%
Eosinophils
Beskrivning

Eosinophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200638
%
Basophils
Beskrivning

Basophils

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C0200641
%
Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose
Beskrivning

Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
UMLS CUI-3
C0439568
Clinical Chemistry - Date and time sample taken
Beskrivning

Clinical Chemistry - Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Has the subject fasted?
Beskrivning

Has the subject fasted

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
BUN
Beskrivning

BUN

Datatyp

float

Alias
UMLS CUI [1]
C0005845
Creatinine
Beskrivning

Creatinine

Datatyp

float

Alias
UMLS CUI [1]
C0201976
Glucose, fasting
Beskrivning

Glucose, fasting

Datatyp

float

Alias
UMLS CUI [1]
C0583513
Sodium
Beskrivning

Sodium

Datatyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beskrivning

Potassium

Datatyp

float

Alias
UMLS CUI [1]
C0202194
Chloride
Beskrivning

Chloride

Datatyp

float

Alias
UMLS CUI [1]
C0201952
Total CO2
Beskrivning

Total CO2

Datatyp

float

Alias
UMLS CUI [1]
C0860709
Calcium
Beskrivning

Calcium

Datatyp

float

Alias
UMLS CUI [1]
C0201925
AST (SGOT)
Beskrivning

AST (SGOT)

Datatyp

float

Alias
UMLS CUI [1]
C0201899
ALT (SGPT)
Beskrivning

ALT (SGPT)

Datatyp

float

Alias
UMLS CUI [1]
C0201836
GGT
Beskrivning

GGT

Datatyp

float

Alias
UMLS CUI [1]
C0202035
Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Datatyp

float

Alias
UMLS CUI [1]
C0201850
Total bilirubin
Beskrivning

Total bilirubin

Datatyp

float

Alias
UMLS CUI [1]
C0201913
Direct bilirubin
Beskrivning

Direct bilirubin

Datatyp

float

Alias
UMLS CUI [1]
C0201916
Uric Acid
Beskrivning

Uric Acid

Datatyp

float

Alias
UMLS CUI [1]
C0041980
Albumin
Beskrivning

Albumin

Datatyp

float

Alias
UMLS CUI [1]
C0201838
Total Protein
Beskrivning

Total Protein

Datatyp

float

Alias
UMLS CUI [1]
C0555903
Urinalysis - 24hrs Post-Dose
Beskrivning

Urinalysis - 24hrs Post-Dose

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
Urinalysis Date and time sample taken
Beskrivning

Urinalysis Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis (Dipstick) Test - Specic gravity
Beskrivning

Urinalysis (Dipstick) Test - Specic gravity

Datatyp

text

Alias
UMLS CUI [1]
C0430383
Urinalysis (Dipstick) Test - pH
Beskrivning

Urinalysis (Dipstick) Test - pH

Datatyp

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Glucose
Beskrivning

Urinalysis (Dipstick) Test - Glucose

Datatyp

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Protein
Beskrivning

Urinalysis (Dipstick) Test - Protein

Datatyp

text

Alias
UMLS CUI [1,1]
C0262923
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Blood
Beskrivning

Urinalysis (Dipstick) Test - Blood

Datatyp

text

Alias
UMLS CUI [1,1]
C0202514
UMLS CUI [1,2]
C0430370
Urinalysis (Dipstick) Test - Ketones
Beskrivning

Urinalysis (Dipstick) Test - Ketones

Datatyp

text

Alias
UMLS CUI [1,1]
C1991100
UMLS CUI [1,2]
C0430370
Was sedimentary microscopy performed?
Beskrivning

Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Datatyp

boolean

Alias
UMLS CUI [1]
C2700128
Urinalysis (Microscopy) Test - Cellular casts
Beskrivning

Urinalysis (Microscopy) Test - Cellular casts

Datatyp

text

Alias
UMLS CUI [1,1]
C2699157
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - Granular casts
Beskrivning

Urinalysis (Microscopy) Test - Granular casts

Datatyp

text

Alias
UMLS CUI [1,1]
C2697521
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - Hyaline casts (qualitative)
Beskrivning

Urinalysis (Microscopy) Test - Hyaline casts (qualitative)

Datatyp

text

Alias
UMLS CUI [1,1]
C1254537
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C0034375
Urinalysis (Microscopy) Test - Hyaline casts (quantitative)
Beskrivning

Urinalysis (Microscopy) Test - Hyaline casts (quantitative)

Datatyp

text

Alias
UMLS CUI [1,1]
C1254537
UMLS CUI [1,2]
C0430397
UMLS CUI [1,3]
C0392762
Urinalysis (Microscopy) Test - RBC
Beskrivning

Urinalysis (Microscopy) Test - RBC

Datatyp

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0430397
Urinalysis (Microscopy) Test - WBC
Beskrivning

Urinalysis (Microscopy) Test - WBC

Datatyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0430397
Tillbaka till toppen

Similar models

Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
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 Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG Number
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
CL Item
ECG 4 (4)
CL Item
ECG 5 (5)
CL Item
ECG 6 (6)
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])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Laboratory Results Data (Haematology) - Pre-Dose
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
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])
Item Group
Laboratory Results Data (Clinical Chemistry) - Pre-Dose
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
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])
Item Group
Urinalysis - Pre-Dose
C0042014 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
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])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-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])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
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])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-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])
Item Group
PET Scan (2)
C0032743 (UMLS CUI-1)
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])
Item Group
fMRI Scan - Post-PET Scan
C0376335 (UMLS CUI-1)
C0032743 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
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])
Item Group
PET Scan (3)
C0032743 (UMLS CUI-1)
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])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-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])
Pharmacokinetics - Sample taken
Code List
Pharmacokinetics - Sample taken
CL Item
Sample taken (1)
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])
Pharmacokinetics - Sample missed or lost
Code List
Pharmacokinetics - Sample missed or lost
CL Item
Sample missed or lost (1)
Item Group
Laboratory Results Data (Haematology) - 24hrs Post-Dose
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
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])
Item Group
Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
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])
Item Group
Urinalysis - 24hrs Post-Dose
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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])
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