ID

30358

Beschreibung

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Visit Documentation 16 Specification: PET Day-2-Day-1

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Stichworte

Versionen (1)
  1. 30.05.18 30.05.18 -
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Hochgeladen am

30. Mai 2018

DOI

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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

Englisch

Visit Documentation 16

1 Formulare  
  1. StudyEvent: ODM
    1. Visit Documentation 16
Date and Type of Visit
Beschreibung

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beschreibung

Time of Visit

Datentyp

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beschreibung

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Datentyp

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Position of Vital Signs Measurement
Beschreibung

In semisupine position

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Actual date of vital signs
Beschreibung

Actual date of vital signs

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Actual time of vital signs
Beschreibung

Actual time of vital signs

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure: Systolic
Beschreibung

Systolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • C
Alias
UMLS CUI [1]
C0005903
C
ECG
Beschreibung

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beschreibung

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET Day-2-Day-1: 12-lead-ECG, Telemetry (0-6hrs)

Datentyp

integer

Alias
UMLS CUI [1]
C1623258
Time from last dose of investigational product until ECG
Beschreibung

Time from last dose of investigational product until ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2348792
Start Date ECG
Beschreibung

Start Date ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Beschreibung

Start Time ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Beschreibung

Stop Date ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Beschreibung

Stop Time ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
If Holter ECG, please select duration of ECG recording
Beschreibung

Duration of ECG recording

Datentyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0449238
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Haematology: Date and time sample taken
Beschreibung

Haematology sampling date and time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Has the subject fasted?
Beschreibung

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Haematology Analytes
Beschreibung

Please answer the following questions for each Haematology Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0018941
Haematology, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Haematology Numeric Result (If numeric result)
Beschreibung

Haematology Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2347373
Haematology Character Result (If character result)
Beschreibung

Haematology Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2350015
Clinical Chemistry
Beschreibung

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Has the subject fasted?
Beschreibung

Fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Beschreibung

Please answer the following questions for each Clinical Chemistry Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0008000
Clinical Chemistry, type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Clinical Chemistry Numeric Result (if Numeric Result)
Beschreibung

Clinical Chemistry Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2347373
Clinical Chemistry Character Result (if Character Result)
Beschreibung

Clinical Chemistry Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Urinalysis - Local
Beschreibung

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1302413
Time sample taken
Beschreibung

Time sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C4064021
Result of dipstick
Beschreibung

Result of dipstick

Datentyp

integer

Alias
UMLS CUI [1,1]
C1160927
UMLS CUI [1,2]
C0587081
If Positive, was sedimentary microscopy performed?
Beschreibung

If Yes, provide details of repeated tests in the add entry section below

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2700128
UMLS CUI [1,2]
C0587081
Urinalysis - Local: Dipstick Details
Beschreibung

Urinalysis - Local: Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0022885
Urinalysis Analytes
Beschreibung

Please answer the following questions for each Urinalysis Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0042014
Urinalysis, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Urinalysis Numeric Result (if Numeric Result)
Beschreibung

Urinalysis Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2347373
Urinalysis Character Result (if Character Result)
Beschreibung

Urinalysis Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2350015
Urinalysis - Local: Microscopy Details
Beschreibung

Urinalysis - Local: Microscopy Details

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C0042014
Microscopy Urinalysis Analytes
Beschreibung

Please answer the following questions for each Urinalysis Analyte

Datentyp

integer

Alias
UMLS CUI [1]
C0430397
Urinalysis, Type of result
Beschreibung

Type of result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0332307
Urinalysis Numeric Result (if Numeric Result)
Beschreibung

Urinalysis Numeric Result

Datentyp

float

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2347373
Urinalysis Character Result (if Character Result)
Beschreibung

Urinalysis Character Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2350015
Pharmacokinetics Urine
Beschreibung

Pharmacokinetics Urine

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
UMLS CUI-3
C0022885
Pharmacokinetics Urine Start Date
Beschreibung

Pharmacokinetics Urine Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0808070
Pharmacokinetics Urine Start Time
Beschreibung

Pharmacokinetics Urine Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1301880
Pharmacokinetics Urine Stop Date
Beschreibung

Pharmacokinetics Urine Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0806020
Pharmacokinetics Urine Stop Time
Beschreibung

Pharmacokinetics Urine Stop Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1522314
Total sample volume
Beschreibung

Total sample volume

Datentyp

float

Maßeinheiten
  • ml
Alias
UMLS CUI [1]
C1278293
ml
Total sample weight
Beschreibung

Total sample weight

Datentyp

float

Maßeinheiten
  • g
Alias
UMLS CUI [1,1]
C0807984
UMLS CUI [1,2]
C0200354
g
Sample pH
Beschreibung

Sample pH

Datentyp

float

Alias
UMLS CUI [1]
C0042044
Questionnaires
Beschreibung

Questionnaires

Alias
UMLS CUI-1
C0034394
Simpson Angus Scale Score
Beschreibung

Simpson Angus Scale Score

Datentyp

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0015371
UMLS CUI [1,3]
C0681889
The Barnes Akathisia Scale Score
Beschreibung

The Barnes Akathisia Scale Score

Datentyp

integer

Alias
UMLS CUI [1]
C3541345
Abnormal Involuntary Movement Scale Score
Beschreibung

Abnormal Involuntary Movement Scale Score

Datentyp

integer

Alias
UMLS CUI [1]
C0450978
Profile of Mood States
Beschreibung

Profile of Mood States

Datentyp

text

Alias
UMLS CUI [1]
C0451394
Columbia Suicide Severity Rating Scale Score
Beschreibung

Columbia Suicide Severity Rating Scale Score

Datentyp

integer

Alias
UMLS CUI [1]
C3888485
Meal
Beschreibung

Meal

Alias
UMLS CUI-1
C3842710
UMLS CUI-2
C0012155
Start date Meal
Beschreibung

Start date Meal

Datentyp

date

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0808070
Start time meal
Beschreibung

Start time meal

Datentyp

time

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C1301880
Type of Meal
Beschreibung

Type of Meal

Datentyp

text

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0332307
Percentage of Meal Consumed
Beschreibung

Percentage of Meal Consumed

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0205197
%
MRI Scan
Beschreibung

MRI Scan

Alias
UMLS CUI-1
C0024485
Has an MRI scan been carried out?
Beschreibung

MRI

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
Yes, date of MRI Scan
Beschreibung

date of MRI

Datentyp

date

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0011008
Examination Number MRI
Beschreibung

Examination Number MRI

Datentyp

text

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
MRI Scan start time
Beschreibung

MRI Scan start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1301880
MRI Scan end time
Beschreibung

MRI Scan end time

Datentyp

time

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1522314
PET Scan Baseline
Beschreibung

PET Scan Baseline

Alias
UMLS CUI-1
C0032743
Date of PET Scan
Beschreibung

Date of PET Scan

Datentyp

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0011008
Examination Number
Beschreibung

Examination Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C0237753
Radiochemical purity at release
Beschreibung

Radiochemical purity at release

Datentyp

integer

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

Radiochemical purity time at release

Datentyp

time

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0678739
UMLS CUI [1,3]
C0040223
Mass of tracer administered
Beschreibung

Mass of tracer administered

Datentyp

float

Maßeinheiten
  • ug
Alias
UMLS CUI [1,1]
C1522485
UMLS CUI [1,2]
C0178602
ug
Volume to be administered (inc diluent)
Beschreibung

Volume to be administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0449468
mL
Bolus activity injected
Beschreibung

Bolus activity injected

Datentyp

float

Maßeinheiten
  • MBq/mL
Alias
UMLS CUI [1,1]
C2986768
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
MBq/mL
Bolus injection start time
Beschreibung

Bolus injection start time

Datentyp

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1301880
Duration of bolus injection
Beschreibung

Duration of bolus injection

Datentyp

integer

Maßeinheiten
  • mins
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0449238
mins
Duration of bolus injection
Beschreibung

Duration of bolus injection

Datentyp

integer

Maßeinheiten
  • secs
Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0449238
secs
Constant infusion activity concentration (at start of infusion)
Beschreibung

Constant infusion activity concentration

Datentyp

float

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0032743
Constant infusion start time
Beschreibung

Constant infusion start time

Datentyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
Constant infusion stop time
Beschreibung

Constant infusion stop time

Datentyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1522314
Volume of constant infusion administered
Beschreibung

Volume of constant infusion administered

Datentyp

float

Maßeinheiten
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
mL
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Visit Documentation 16

1 Formulare
  1. StudyEvent: ODM
    1. Visit Documentation 16
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
PET Day-2-Day-1  (1)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Position of Vital Signs Measurement
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Position of Vital Signs Measurement
Code List
Position of Vital Signs Measurement
CL Item
Semi Supine (1)
Actual date of vital signs
Item
Actual date of vital signs
date
C2826644 (UMLS CUI [1])
Actual time of vital signs
Item
Actual time of vital signs
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood Pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
CL Item
Telemetry ECG (2)
Item
Time from last dose of investigational product until ECG
integer
C1623258 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Time from last dose of investigational product until ECG
CL Item
Pre-dose 1 (1)
CL Item
Pre-dose 2 (2)
CL Item
Pre-dose 3 (3)
CL Item
1h (4)
CL Item
2h (5)
CL Item
4h (6)
CL Item
8h (7)
CL Item
12h (8)
CL Item
24h (9)
CL Item
36h (10)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
If Holter ECG, please select duration of ECG recording
integer
C1623258 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of ECG recording
Code List
If Holter ECG, please select duration of ECG recording
CL Item
0-24hrs (1)
CL Item
0-48hrs (2)
Item Group
Haematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Haematology sampling date and time
Item
Haematology: Date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Haematology Analytes
integer
C0018941 (UMLS CUI [1])
Haematology Analytes
Code List
Haematology Analytes
CL Item
WBC (1)
C0023508 (UMLS CUI-1)
(Comment:en)
CL Item
RBC (2)
C0014772 (UMLS CUI-1)
(Comment:en)
CL Item
Haemoglobin (3)
C0518015 (UMLS CUI-1)
(Comment:en)
CL Item
Haematocrit (4)
C0018935 (UMLS CUI-1)
(Comment:en)
CL Item
Neutrophils (5)
C0948762 (UMLS CUI-1)
(Comment:en)
CL Item
Lymphocytes (6)
C0200635 (UMLS CUI-1)
(Comment:en)
CL Item
Monocytes (7)
C0200637 (UMLS CUI-1)
(Comment:en)
CL Item
Eosinophils (8)
C0200638 (UMLS CUI-1)
(Comment:en)
CL Item
Basophils (9)
C0200641 (UMLS CUI-1)
(Comment:en)
CL Item
Platelets (10)
C0032181 (UMLS CUI-1)
(Comment:en)
CL Item
Reticulocytes (11)
C0206161 (UMLS CUI-1)
(Comment:en)
CL Item
MCV (12)
C1948043 (UMLS CUI-1)
(Comment:en)
CL Item
MCH (13)
C0369183 (UMLS CUI-1)
(Comment:en)
CL Item
MCHC (14)
C0474535 (UMLS CUI-1)
(Comment:en)
Item
Haematology, Type of result
integer
C0474523 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Haematology, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Haematology Numeric Result
Item
Haematology Numeric Result (If numeric result)
float
C0474523 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Haematology Character Result
Item
Haematology Character Result (If character result)
text
C0474523 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Fasting
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Clinical Chemistry Analytes
integer
C0008000 (UMLS CUI [1])
Clinical Chemistry Analytes
Code List
Clinical Chemistry Analytes
CL Item
ALT (1)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
AST (2)
C0201836 (UMLS CUI-1)
(Comment:en)
CL Item
Total Bilirubin (3)
C0201913 (UMLS CUI-1)
(Comment:en)
CL Item
Direct Bilirubin  (4)
C0201916 (UMLS CUI-1)
(Comment:en)
CL Item
Glucose (5)
C0337438 (UMLS CUI-1)
(Comment:en)
CL Item
GGT (6)
C0202035 (UMLS CUI-1)
(Comment:en)
CL Item
Total Protein  (7)
C0555903 (UMLS CUI-1)
(Comment:en)
CL Item
Albumin (8)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
Potassium (9)
C0202194 (UMLS CUI-1)
(Comment:en)
CL Item
Sodium (10)
C0337443 (UMLS CUI-1)
(Comment:en)
CL Item
Chloride (11)
C0201952 (UMLS CUI-1)
(Comment:en)
CL Item
Urea (12)
C0523961 (UMLS CUI-1)
(Comment:en)
CL Item
Creatinine (13)
C0201975 (UMLS CUI-1)
(Comment:en)
CL Item
Calcium (14)
C0201925 (UMLS CUI-1)
(Comment:en)
CL Item
Bicarbonate (15)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
Tryglyceride (16)
C0202236 (UMLS CUI-1)
(Comment:en)
CL Item
Cholesterol (17)
C0201950 (UMLS CUI-1)
(Comment:en)
CL Item
LDL (18)
C0428474 (UMLS CUI-1)
(Comment:en)
CL Item
HDL (19)
C0428472 (UMLS CUI-1)
(Comment:en)
CL Item
Uric Acid  (20)
C0202239 (UMLS CUI-1)
(Comment:en)
CL Item
Alkaline Phosphatase  (21)
C0201850 (UMLS CUI-1)
(Comment:en)
Item
Clinical Chemistry, type of result
integer
C0008000 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Clinical Chemistry, type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Clinical Chemistry Numeric Result
Item
Clinical Chemistry Numeric Result (if Numeric Result)
float
C0008000 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Clinical Chemistry Character Result
Item
Clinical Chemistry Character Result (if Character Result)
text
C0008000 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Urinalysis - Local
C0042014 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0200354 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken
time
C0200354 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
Result of dipstick
integer
C1160927 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
No result (1)
CL Item
Negative (2)
CL Item
Positive (3)
sedimentary microscopy
Item
If Positive, was sedimentary microscopy performed?
boolean
C2700128 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Item
Urinalysis Analytes
integer
C0042014 (UMLS CUI [1])
Urinalysis Analytes
Code List
Urinalysis Analytes
CL Item
Protein (1)
C0430371 (UMLS CUI-1)
(Comment:en)
CL Item
Glucose (2)
C0430376 (UMLS CUI-1)
(Comment:en)
CL Item
Ketones (3)
C0430377 (UMLS CUI-1)
(Comment:en)
CL Item
Blood (4)
C0430372 (UMLS CUI-1)
(Comment:en)
CL Item
pH (5)
C0042044 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
(Comment:en)
CL Item
Specific Gravity (6)
C0202517 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
(Comment:en)
Item
Urinalysis, Type of result
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Urinalysis, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis Numeric Result
Item
Urinalysis Numeric Result (if Numeric Result)
float
C0042014 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Urinalysis Character Result
Item
Urinalysis Character Result (if Character Result)
text
C0042014 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Microscopy Details
C0430397 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
Item
Microscopy Urinalysis Analytes
integer
C0430397 (UMLS CUI [1])
Microscopy Urinalysis Analytes
Code List
Microscopy Urinalysis Analytes
CL Item
White blood cells  (1)
C0023508 (UMLS CUI-2)
C0430397 (UMLS CUI-3)
(Comment:en)
CL Item
Red blood cells  (2)
C0014772 (UMLS CUI-1)
C0430397 (UMLS CUI-2)
(Comment:en)
CL Item
Hyaline casts  (3)
C0427894 (UMLS CUI-1)
(Comment:en)
CL Item
Cellular casts (4)
C2699157 (UMLS CUI-1)
C0430397 (UMLS CUI-2)
(Comment:en)
Item
Urinalysis, Type of result
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of result
Code List
Urinalysis, Type of result
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Urinalysis Numeric Result
Item
Urinalysis Numeric Result (if Numeric Result)
float
C0042014 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Urinalysis Character Result
Item
Urinalysis Character Result (if Character Result)
text
C0042014 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Urine
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Pharmacokinetics Urine Start Date
Item
Pharmacokinetics Urine Start Date
date
C0022885 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Pharmacokinetics Urine Start Time
Item
Pharmacokinetics Urine Start Time
time
C0022885 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Pharmacokinetics Urine Stop Date
Item
Pharmacokinetics Urine Stop Date
date
C0022885 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Pharmacokinetics Urine Stop Time
Item
Pharmacokinetics Urine Stop Time
time
C0022885 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Total sample volume
Item
Total sample volume
float
C1278293 (UMLS CUI [1])
Total sample weight
Item
Total sample weight
float
C0807984 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Sample pH
Item
Sample pH
float
C0042044 (UMLS CUI [1])
Item Group
Questionnaires
C0034394 (UMLS CUI-1)
Simpson Angus Scale Score
Item
Simpson Angus Scale Score
integer
C0041755 (UMLS CUI [1,1])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
The Barnes Akathisia Scale Score
Item
The Barnes Akathisia Scale Score
integer
C3541345 (UMLS CUI [1])
Abnormal Involuntary Movement Scale Score
Item
Abnormal Involuntary Movement Scale Score
integer
C0450978 (UMLS CUI [1])
Profile of Mood States
Item
Profile of Mood States
text
C0451394 (UMLS CUI [1])
Columbia Suicide Severity Rating Scale Score
Item
Columbia Suicide Severity Rating Scale Score
integer
C3888485 (UMLS CUI [1])
Item Group
Meal
C3842710 (UMLS CUI-1)
C0012155 (UMLS CUI-2)
Start date Meal
Item
Start date Meal
date
C3842710 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time meal
Item
Start time meal
time
C3842710 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Type of Meal
Item
Type of Meal
text
C3842710 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Percentage of Meal Consumed
Item
Percentage of Meal Consumed
float
C3842710 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
MRI Scan
C0024485 (UMLS CUI-1)
MRI
Item
Has an MRI scan been carried out?
boolean
C0024485 (UMLS CUI [1])
date of MRI
Item
Yes, date of MRI Scan
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Examination Number MRI
Item
Examination Number MRI
text
C0024485 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
MRI Scan start time
Item
MRI Scan start time
time
C0024485 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
MRI Scan end time
Item
MRI Scan end time
time
C0024485 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
PET Scan Baseline
C0032743 (UMLS CUI-1)
Date of PET Scan
Item
Date of PET Scan
date
C0032743 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Examination Number
Item
Examination Number
text
C0032743 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
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
Item
Volume to be administered (inc diluent)
float
C0009924 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Bolus activity injected
Item
Bolus activity injected
float
C2986768 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
Bolus injection start time
Item
Bolus injection start time
time
C1511237 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Duration of bolus injection
Item
Duration of bolus injection
integer
C1511237 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of bolus injection
Item
Duration of bolus injection
integer
C1511237 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Constant infusion activity concentration
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])
Constant infusion start time
Item
Constant infusion start time
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Constant infusion stop time
Item
Constant infusion stop time
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])
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