ID

30334

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: Visit Documentation 4 Specification: Cohort 1-4 RD Day-1

Link

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

Keywords

Versions (1)
  1. 5/29/18 5/29/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 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

Visit Documentation 4

1 forms  
  1. StudyEvent: ODM
    1. Visit Documentation 4
Date and Type of Visit
Description

Date and Type of Visit

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

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

text

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

Date of Visit/Assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Description

Time of Visit

Data type

time

Alias
UMLS CUI [1]
C1320304
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Description

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

Data type

integer

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Time from last dose of investigational product until Vital Signs measurement
Description

Time from last dose of investigational product until Vital Signs measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0518766
Position of Vital Signs Measurement
Description

Cohort 1-4 RD Day-1: at 2h and 3h in standing position

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
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
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
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Description

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) Cohort 1-4 RD Day-1: 12-lead-ECG, Telemetry

Data type

integer

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

Time from last dose of investigational product until ECG

Data type

integer

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

Start Date ECG

Data type

date

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

Start Time ECG

Data type

time

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

Stop Date ECG

Data type

date

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

Stop Time ECG

Data type

time

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

Duration of ECG recording

Data type

integer

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

Haematology

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

Haematology sampling date and time

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

Result of dipstick

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 of repeated tests in the add entry section below

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

Alias
UMLS CUI [1]
C0430397
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 Hormones 1
Description

Local Laboratory - Clinical Chemistry Hormones 1

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0019932
UMLS CUI-3
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
Local Laboratory - Clinical Chemistry Hormones 2
Description

Local Laboratory - Clinical Chemistry Hormones 2

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0019932
UMLS CUI-3
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
Time from last dose of investigational product until Hormones 2 measurement
Description

Time from last dose of investigational product until Hormones 2 measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
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
Local Laboratory - Clinical Chemistry Hormones 3
Description

Local Laboratory - Clinical Chemistry Hormones 3

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0019932
UMLS CUI-3
C0022885
Laboratory ID
Description

Laboratory ID

Data type

text

Alias
UMLS CUI [1]
C2986056
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
Time from last dose of investigational product until Hormones 3 measurement
Description

Time from last dose of investigational product until Hormones 3 measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
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
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
Questionnaires
Description

Questionnaires

Alias
UMLS CUI-1
C0034394
Simpson Angus Scale Score
Description

Simpson Angus Scale Score

Data type

integer

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

The Barnes Akathisia Scale Score

Data type

integer

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

Abnormal Involuntary Movement Scale Score

Data type

integer

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

Profile of Mood States

Data type

text

Alias
UMLS CUI [1]
C0451394
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Description

Date of dose

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Description

Time of dose

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics Blood
Description

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Time from last dose of investigational product until Clinical Chemistry measurement
Description

Time from last dose of investigational product until Clinical Chemistry measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Actual Time of Pharmacokinetics Blood
Description

Actual Time of Pharmacokinetics Blood

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Meal
Description

Meal

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

Start date Meal

Data type

date

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

Start time meal

Data type

time

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

Type of Meal

Data type

text

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

Percentage of Meal Consumed

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0205197
%
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Visit Documentation 4

1 forms
  1. StudyEvent: ODM
    1. Visit Documentation 4
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Cohort 1-4 SD Day 1 (1)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Time from last dose of investigational product until Vital Signs measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Timepoint of Vital Signs
Code List
Time from last dose of investigational product until Vital Signs measurement
CL Item
Predose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
3h (4)
CL Item
4h (5)
CL Item
5h (6)
CL Item
6h (7)
CL Item
8h (8)
CL Item
12h (9)
CL Item
24h (10)
CL Item
36h (11)
CL Item
48h (12)
CL Item
72h (13)
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
Supine (1)
CL Item
Standing (2)
CL Item
Semi Supine (3)
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
Holter ECG (2)
CL Item
Telemetry ECG (3)
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
Local Laboratory - Clinical Chemistry Hormones 1
C0008000 (UMLS CUI-1)
C0019932 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
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
Total Testosterone  (1)
C0202230 (UMLS CUI-1)
(Comment:en)
CL Item
Free Testosterone  (2)
C0037663 (UMLS CUI-1)
(Comment:en)
CL Item
LH (3)
C0202227 (UMLS CUI-1)
(Comment:en)
CL Item
FSH (4)
C0202228 (UMLS CUI-1)
(Comment:en)
CL Item
Estradiol (Females only) (5)
C0202123 (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
Local Laboratory - Clinical Chemistry Hormones 2
C0008000 (UMLS CUI-1)
C0019932 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
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])
Item
Time from last dose of investigational product until Hormones 2 measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Time to last dose of investigational product
Code List
Time from last dose of investigational product until Hormones 2 measurement
CL Item
Predose (1)
CL Item
2hrs (2)
CL Item
8hrs (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)
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
Local Laboratory - Clinical Chemistry Hormones 3
C0008000 (UMLS CUI-1)
C0019932 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
Laboratory ID
Item
Laboratory ID
text
C2986056 (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])
Item
Time from last dose of investigational product until Hormones 3 measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Time to last dose of investigational product
Code List
Time from last dose of investigational product until Hormones 3 measurement
CL Item
Predose (1)
CL Item
1h (2)
CL Item
2h (3)
CL Item
4h (4)
CL Item
8h (5)
CL Item
12h (6)
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
Prolactin (1)
C0202230 (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
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
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])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Time from last dose of investigational product until Clinical Chemistry measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Timepoint of Laboratory Procedure
Code List
Time from last dose of investigational product until Clinical Chemistry measurement
CL Item
Predose (1)
CL Item
0,5h (2)
CL Item
1h (3)
CL Item
1,5h (4)
CL Item
2h (5)
CL Item
3h (6)
CL Item
4h (7)
CL Item
5h (8)
CL Item
6h (9)
CL Item
8h (10)
CL Item
12h (11)
CL Item
24h (12)
Actual Time of Pharmacokinetics Blood
Item
Actual Time of Pharmacokinetics Blood
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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])
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