ID

29969

Description

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: Screening

Link

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

Keywords

Versions (2)
  1. 4/24/18 4/24/18 -
  2. 4/30/18 4/30/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 30, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

English

Screening

1 forms  
  1. StudyEvent: ODM
    1. Screening
Date of Visit
Description

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Cohort
Description

Cohort

Alias
UMLS CUI-1
C0599755
UMLS CUI-2
C0008976
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
If female, record childbearing potential
Description

Childbearing potential

Data type

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry: African American/African Heritage?
Description

African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
Geographic ancestry: American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Geographic ancestry: Asian - Central/South Asian Heritage
Description

Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Geographic ancestry: Asian - East Asian Heritage
Description

Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0003983
Geographic ancestry: Japanese Heritage
Description

Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Geographic ancestry: South East Asian Heritage
Description

South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Geographic ancestry: Hawaiian or Other Pacific Islander
Description

Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
Geographic ancestry: White - Arabic/North African Heritage
Description

White - Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C0026068
Geographic ancestry: White - White/Caucasian!European Heritage
Description

White - White/Caucasian!European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date of vital signs
Description

Actual date of vital signs

Data type

date

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

Actual time of vital signs

Data type

time

Alias
UMLS CUI [1]
C2826762
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Alias
UMLS CUI [1]
C1305855
Position
Description

Position

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Blood Pressure: Systolic
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Description

Respiration rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • C
Alias
UMLS CUI [1]
C0005903
C
12-lead ECG
Description

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
UMLS CUI-3
C0031809
Start Date of ECG
Description

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Description

Start Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
Method of QTC Measurement
Description

Method of QTC Measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1299991
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
Description

QTcB

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
Description

QTcF

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
Description

RR interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Description

(complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE)

Data type

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Menstrual cycle profile
Description

Menstrual cycle profile

Alias
UMLS CUI-1
C0025329
Date of start of last menstrual period
Description

Date of start of last menstrual period

Data type

date

Alias
UMLS CUI [1,1]
C0425932
UMLS CUI [1,2]
C0808070
Date of end of last menstrual period
Description

Date of end of last menstrual period

Data type

date

Alias
UMLS CUI [1,1]
C0425932
UMLS CUI [1,2]
C0806020
Haematology
Description

Haematology

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

Day Month Year Hr : Min (00:00 - 23:59)

Data type

datetime

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

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Haematology Analytes
Description

Please answer the following questions for each Haematology Analyte

Data type

integer

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

Type of result

Data type

integer

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

Haematology Numeric Result

Data type

float

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

Haematology Character Result

Data type

text

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

Clinical Chemistry

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

Date and time sample taken

Data type

datetime

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

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Description

Please answer the following questions for each Clinical Chemistry Analyte

Data type

integer

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

Type of result

Data type

integer

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

Clinical Chemistry Numeric Result

Data type

float

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

Clinical Chemistry Character Result

Data type

text

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

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Date sample taken
Description

Date sample taken

Data type

date

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

Time sample taken

Data type

time

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

If positive, record results of individual tests below.

Data type

integer

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

If Yes, provide details on the MICROSCOPY form

Data type

boolean

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

Urinalysis - Local: Dipstick Details

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

Please answer the following questions for each Urinalysis Analyte

Data type

integer

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

Type of result

Data type

integer

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

Urinalysis Numeric Result

Data type

float

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

Urinalysis Character Result

Data type

text

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

Urinalysis - Local: Microscopy Details

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

Please answer the following questions for each Urinalysis Analyte

Data type

integer

Urinalysis, Type of result
Description

Type of result

Data type

integer

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

Urinalysis Numeric Result

Data type

float

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

Urinalysis Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C2350015
Local Laboratory - Clinical Chemistry
Description

Local Laboratory - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Date and time sample taken
Description

Date and time sample taken

Data type

datetime

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

Fasting

Data type

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Description

Please answer the following questions for each Clinical Chemistry Analyte

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0022885
Clinical Chemistry, type of result
Description

Type of result

Data type

integer

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

Clinical Chemistry Numeric Result

Data type

float

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

Clinical Chemistry Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Columbia Suicide Rating scale
Description

Columbia Suicide Rating scale

Alias
UMLS CUI-1
C3888485
Score of Columbia Suicide Severity Rating Scale
Description

Score of Columbia Suicide Severity Rating Scale

Data type

integer

Alias
UMLS CUI [1,1]
C3888485
UMLS CUI [1,2]
C0449820
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Was the subject able to be randomised?
Description

Randomisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C2348568
If Yes, provide randomisation number
Description

Randomisation number

Data type

integer

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

Date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
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Similar models

Screening

1 forms
  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Cohort
C0599755 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort I (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
PET (4)
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (2)
CL Item
Male (1)
Item
If female, record childbearing potential
integer
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
If female, record childbearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Race
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
African American/African Heritage
Item
Geographic ancestry: African American/African Heritage?
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
Geographic ancestry: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Geographic ancestry: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Geographic ancestry: Asian - East Asian Heritage
boolean
C0003983 (UMLS CUI [1])
Japanese Heritage
Item
Geographic ancestry: Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
South East Asian Heritage
Item
Geographic ancestry: South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Hawaiian or Other Pacific Islander
Item
Geographic ancestry: Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
Geographic ancestry: White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C0026068 (UMLS CUI [2])
White - White/Caucasian!European Heritage
Item
Geographic ancestry: White - White/Caucasian!European Heritage
boolean
C0043157 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-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])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item
Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Position
Code List
Position
CL Item
Semi Supine (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
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Method of QTC Measurement
integer
C0489625 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
Method ofQTC Measurement
Code List
Method of QTC Measurement
CL Item
Machine (1)
CL Item
Manual (2)
QTcB
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
QTcF
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
float
C1882513 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
RR interval
Item
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
float
C0489636 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
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)
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Menstrual cycle profile
C0025329 (UMLS CUI-1)
Date of start of last menstrual period
Item
Date of start of last menstrual period
date
C0425932 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of end of last menstrual period
Item
Date of end of last menstrual period
date
C0425932 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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
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
Local Laboratory - Clinical Chemistry
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
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 [1,1])
C0022885 (UMLS CUI [1,2])
Clinical Chemistry Analytes
Code List
Clinical Chemistry Analytes
CL Item
TSH (1)
C0202230 (UMLS CUI-1)
(Comment:en)
CL Item
GH (2)
C0037663 (UMLS CUI-1)
(Comment:en)
CL Item
Total Testosterone  (3)
C0202227 (UMLS CUI-1)
(Comment:en)
CL Item
Free Testosterone  (4)
C0202228 (UMLS CUI-1)
(Comment:en)
CL Item
LH (5)
C0202123 (UMLS CUI-1)
(Comment:en)
CL Item
FSH (6)
C0202022 (UMLS CUI-1)
(Comment:en)
CL Item
Estradiol (Females only) (7)
C0337434 (UMLS CUI-1)
(Comment:en)
CL Item
Prolactin (8)
C0373706 (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
Columbia Suicide Rating scale
C3888485 (UMLS CUI-1)
Score of Columbia Suicide Severity Rating Scale
Item
Score of Columbia Suicide Severity Rating Scale
integer
C3888485 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Randomisation
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Randomisation number
Item
If Yes, provide randomisation number
integer
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])
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