ID

29971

Beskrivning

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: Follow-up

Länk

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

Nyckelord

Versioner (2)
  1. 2018-04-24 2018-04-24 -
  2. 2018-04-30 2018-04-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 april 2018

DOI

För en begäran logga in.

Licens

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

Engelsk

Follow-up

1 Formulär  
  1. StudyEvent: ODM
    1. Follow-up
Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Randomisation
Beskrivning

Randomisation

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

Randomisation

Datatyp

boolean

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

Randomisation number

Datatyp

integer

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
Status of Treatment Blind
Beskrivning

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the Treatment Blind broken during the study?
Beskrivning

If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate

Datatyp

boolean

Alias
UMLS CUI [1]
C3897431
Date Treatment Blind broken
Beskrivning

Date Treatment Blind broken

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time Treatment Blind broken
Beskrivning

Time Treatment Blind broken

Datatyp

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Beskrivning

Reason blind broken

Datatyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason blind broken, specify
Beskrivning

Reason blind broken

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Vital Signs
Beskrivning

Vital Signs

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

Actual date of vital signs

Datatyp

date

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

Actual time of vital signs

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beskrivning

Body mass index

Datatyp

float

Alias
UMLS CUI [1]
C1305855
Position
Beskrivning

Position

Datatyp

integer

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

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beskrivning

Respiration rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • C
Alias
UMLS CUI [1]
C0005903
C
12-lead ECG
Beskrivning

12-lead ECG

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

Start Date of ECG

Datatyp

date

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

Start Time of ECG

Datatyp

time

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

Heart Rate

Datatyp

integer

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

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

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

Method of QTC Measurement

Datatyp

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
Beskrivning

QTcB

Datatyp

float

Måttenheter
  • 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
Beskrivning

QTcF

Datatyp

float

Måttenheter
  • 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
Beskrivning

RR interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Beskrivning

(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)

Datatyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Beskrivning

lf the subject completed the study »Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. lf the subject withdrew »Date of decision to withdraw must match the date of subject withdrawal. »Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An 'actual contact' is defined as an interaction between the subject and the investigator or investigator 's designee, where the investigator/designee has the opportunity to query the subject about the subject's status. This would include clinic visits and telephone contacts, buy normally would not include mail correspondence or third party reports.

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beskrivning

subject withdrawn from the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, complete details: Date of decision to withdraw
Beskrivning

Date of decision to withdraw

Datatyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Beskrivning

Primary reason for withdrawal

Datatyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Case book ready for signature
Beskrivning

Data owner should check the box when data cleaning is complete

Datatyp

integer

Alias
UMLS CUI [1]
C2346576
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beskrivning

If Yes, complete the Paper Pregnancy Notification form

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
Did a female partner of the male subject become pregnant during the study?
Beskrivning

If Yes, complete the paper Pregnancy Notification form Check Not Applicable if female partner not of childbearing potential or no female partner

Datatyp

integer

Alias
UMLS CUI [1]
C0919624
Menstrual cycle profile
Beskrivning

Menstrual cycle profile

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

Date of start of last menstrual period

Datatyp

date

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

Date of end of last menstrual period

Datatyp

date

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

Haematology

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

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

Datatyp

datetime

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

Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Haematology Analytes
Beskrivning

Please answer the following questions for each Haematology Analyte

Datatyp

integer

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

Type of result

Datatyp

integer

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

Haematology Numeric Result

Datatyp

float

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

Haematology Character Result

Datatyp

text

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

Clinical Chemistry

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

Date and time sample taken

Datatyp

datetime

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

Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Beskrivning

Please answer the following questions for each Clinical Chemistry Analyte

Datatyp

integer

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

Type of result

Datatyp

integer

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

Clinical Chemistry Numeric Result

Datatyp

float

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

Clinical Chemistry Character Result

Datatyp

text

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

Urinalysis - Local

Alias
UMLS CUI-1
C0042014
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

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

Time sample taken

Datatyp

time

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

If positive, record results of individual tests below.

Datatyp

integer

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

If Yes, provide details on the MICROSCOPY form

Datatyp

boolean

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

Urinalysis - Local: Dipstick Details

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

Please answer the following questions for each Urinalysis Analyte

Datatyp

integer

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

Type of result

Datatyp

integer

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

Urinalysis Numeric Result

Datatyp

float

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

Urinalysis Character Result

Datatyp

text

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

Urinalysis - Local: Microscopy Details

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

Please answer the following questions for each Urinalysis Analyte

Datatyp

integer

Urinalysis, Type of result
Beskrivning

Type of result

Datatyp

integer

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

Urinalysis Numeric Result

Datatyp

float

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

Urinalysis Character Result

Datatyp

text

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

Local Laboratory - Clinical Chemistry

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

Date and time sample taken

Datatyp

datetime

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

Fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0015663
Clinical Chemistry Analytes
Beskrivning

Please answer the following questions for each Clinical Chemistry Analyte

Datatyp

integer

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

Type of result

Datatyp

integer

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

Clinical Chemistry Numeric Result

Datatyp

float

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

Clinical Chemistry Character Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C2350015
Simpson Angus Scale
Beskrivning

Simpson Angus Scale

Alias
UMLS CUI-1
C0041755
UMLS CUI-2
C0015371
UMLS CUI-3
C0681889
Simpson Angus Scale Score
Beskrivning

Simpson Angus Scale Score

Datatyp

integer

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

The Barnes Akathisia Scale

Alias
UMLS CUI-1
C3541345
The Barnes Akathisia Scale Score
Beskrivning

The Barnes Akathisia Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C3541345
Abnormal Involuntary Movement Scale
Beskrivning

Abnormal Involuntary Movement Scale

Alias
UMLS CUI-1
C0450978
Abnormal Involuntary Movement Scale Score
Beskrivning

Abnormal Involuntary Movement Scale Score

Datatyp

integer

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

Profile of Mood States

Alias
UMLS CUI-1
C0451394
Profile of Mood States Score
Beskrivning

Profile of Mood States Score

Datatyp

integer

Alias
UMLS CUI [1]
C0451394
Columbia Suicide Rating scale
Beskrivning

Columbia Suicide Rating scale

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

Score of Columbia Suicide Severity Rating Scale

Datatyp

integer

Alias
UMLS CUI [1]
C3888485
Tillbaka till toppen

Similar models

Follow-up

1 Formulär
  1. StudyEvent: ODM
    1. Follow-up
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
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])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Treatment Blind broken
Item
Was the Treatment Blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date Treatment Blind broken
Item
Date Treatment Blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Treatment Blind broken
Item
Time Treatment Blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Reason blind broken
Item
If other reason blind broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
subject withdrawn from the study
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Date of decision to withdraw
Item
If Yes, complete details: Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event, Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. (1)
CL Item
Protocol deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Withdrew consent (5)
Item
Case book ready for signature
integer
C2346576 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (1)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
pregnant
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item
Did a female partner of the male subject become pregnant during the study?
integer
C0919624 (UMLS CUI [1])
female partner of the male subject become pregnant
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
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
Simpson Angus Scale
C0041755 (UMLS CUI-1)
C0015371 (UMLS CUI-2)
C0681889 (UMLS CUI-3)
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])
Item Group
The Barnes Akathisia Scale
C3541345 (UMLS CUI-1)
The Barnes Akathisia Scale Score
Item
The Barnes Akathisia Scale Score
integer
C3541345 (UMLS CUI [1])
Item Group
Abnormal Involuntary Movement Scale
C0450978 (UMLS CUI-1)
Abnormal Involuntary Movement Scale Score
Item
Abnormal Involuntary Movement Scale Score
integer
C0450978 (UMLS CUI [1])
Item Group
Profile of Mood States
C0451394 (UMLS CUI-1)
Profile of Mood States Score
Item
Profile of Mood States Score
integer
C0451394 (UMLS CUI [1])
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])
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