ID

29851

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: Follow-up

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 24, 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

Follow-up

1 forms  
  1. StudyEvent: ODM
    1. Follow-up
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
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
Status of Treatment Blind
Description

Status of Treatment Blind

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

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

Data type

boolean

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

Date Treatment Blind broken

Data type

date

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

Time Treatment Blind broken

Data type

time

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

Reason blind broken

Data type

integer

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

Reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
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
Study Conclusion
Description

Study Conclusion

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

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.

Data type

date

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Was the subject withdrawn from the study?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

subject withdrawn from the study

Data type

boolean

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

Date of decision to withdraw

Data type

date

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

Primary reason for withdrawal

Data type

integer

Case book ready for signature
Description

Data owner should check the box when data cleaning is complete

Data type

integer

Alias
UMLS CUI [1]
C2346576
Office Use 1
Description

Office Use 1

Data type

boolean

Alias
UMLS CUI [1]
C0442603
Pregnancy Information
Description

Pregnancy Information

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

If Yes, complete the Paper Pregnancy Notification form

Data type

boolean

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

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

Data type

integer

Alias
UMLS CUI [1]
C0919624
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, 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
White blood cell count (WBC)
Description

White blood cell count

Data type

text

Alias
UMLS CUI [1]
C0023508
Red blood cell count (RBC)
Description

Red blood cell count

Data type

text

Alias
UMLS CUI [1]
C0014772
Haemoglobin (Hb)
Description

Haemoglobin

Data type

text

Alias
UMLS CUI [1]
C0518015
Haematocrit (HCT)
Description

Haematocrit

Data type

text

Alias
UMLS CUI [1]
C0018935
Neutrophil count (absolute)
Description

Neutrophil count

Data type

text

Alias
UMLS CUI [1]
C0948762
Lymphocytes
Description

Lymphocyte count

Data type

text

Alias
UMLS CUI [1]
C0200635
Monocytes
Description

Monocyte count

Data type

text

Alias
UMLS CUI [1]
C0200637
Eosinophils
Description

Eosinophil count

Data type

text

Alias
UMLS CUI [1]
C0200638
Basophis
Description

Basophil count

Data type

text

Alias
UMLS CUI [1]
C0200641
Platelets
Description

Platelet count

Data type

text

Alias
UMLS CUI [1]
C0032181
Reticulocytes
Description

Reticulocyte count

Data type

text

Alias
UMLS CUI [1]
C0206161
Mean cell volume (MCV)
Description

Mean cell volume

Data type

text

Alias
UMLS CUI [1]
C1948043
Mean cell haemoglobin (MCH)
Description

Mean cell haemoglobin

Data type

text

Alias
UMLS CUI [1]
C0369183
Mean cell haemoglobin concentration (MCHC)
Description

Mean cell haemoglobin concentration

Data type

text

Alias
UMLS CUI [1]
C0474535
Clinical Chemistry
Description

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, 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
Alkaline phasphatase
Description

Alkaline phosphatase

Data type

text

Alias
UMLS CUI [1]
C0201850
Alanine transaminase
Description

Alanine transaminase

Data type

text

Alias
UMLS CUI [1]
C0201836
Total Bilirubin
Description

Total Bilirubin

Data type

text

Alias
UMLS CUI [1]
C0201913
Direct Bilirubin
Description

Direct Bilirubin

Data type

text

Alias
UMLS CUI [1]
C0201916
Glucose
Description

Glucose

Data type

text

Alias
UMLS CUI [1]
C0337438
Gamma-glutamyl transpeptidase
Description

Gamma-glutamyl transpeptidase

Data type

text

Alias
UMLS CUI [1]
C0202035
Total protein
Description

Total protein

Data type

text

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Data type

text

Alias
UMLS CUI [1]
C0201838
Potassium
Description

Potassium

Data type

text

Alias
UMLS CUI [1]
C0202194
Sodium
Description

Sodium

Data type

text

Alias
UMLS CUI [1]
C0337443
Chloride
Description

Chloride

Data type

text

Alias
UMLS CUI [1]
C0201952
Urea
Description

Urea

Data type

text

Alias
UMLS CUI [1]
C0523961
Creatinine
Description

Creatinine

Data type

text

Alias
UMLS CUI [1]
C0201975
Calcium
Description

Calcium

Data type

text

Alias
UMLS CUI [1]
C0201925
Bicarbonate
Description

Bicarbonate

Data type

text

Alias
UMLS CUI [1]
C0202059
Triglycerides
Description

Triglycerides

Data type

text

Alias
UMLS CUI [1]
C0202236
Cholesterol
Description

Cholesterol

Data type

text

Alias
UMLS CUI [1]
C0201950
LDL
Description

LDL

Data type

text

Alias
UMLS CUI [1]
C0428474
HDL
Description

HDL

Data type

text

Alias
UMLS CUI [1]
C0428472
Uric Acid
Description

Uric Acid

Data type

text

Alias
UMLS CUI [1]
C0202239
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

text

Alias
UMLS CUI [1]
C0201850
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, 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
Urine Protein
Description

Urine Protein

Data type

text

Alias
UMLS CUI [1]
C0430371
Urine Glucose
Description

Urine Glucose

Data type

text

Alias
UMLS CUI [1]
C0430376
Urine Ketones
Description

Urine Ketones

Data type

text

Alias
UMLS CUI [1]
C0430377
Urine Blood
Description

Urine Blood

Data type

text

Alias
UMLS CUI [1]
C0430372
Urine pH
Description

Urine pH

Data type

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urine Specific Gravity
Description

Urine Specific Gravity

Data type

text

Alias
UMLS CUI [1,1]
C0202517
UMLS CUI [1,2]
C0430370
Urinalysis - Local: Microscopy Details
Description

Urinalysis - Local: Microscopy Details

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
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
White blood cells
Description

White blood cells

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0430397
Red Blood Cells
Description

Red Blood Cells

Data type

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0430397
Hyaline casts
Description

Hyaline casts

Data type

text

Alias
UMLS CUI [1]
C0427894
Cellular casts
Description

Cellular casts

Data type

text

Alias
UMLS CUI [1,1]
C2699157
UMLS CUI [1,2]
C0430397
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, 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
TSH
Description

TSH

Data type

text

Alias
UMLS CUI [1]
C0202230
GH
Description

GH

Data type

text

Alias
UMLS CUI [1]
C0037663
Total Testosterone
Description

Total Testosterone

Data type

text

Alias
UMLS CUI [1]
C0202227
Free Testosterone
Description

Free Testosterone

Data type

text

Alias
UMLS CUI [1]
C0202228
LH
Description

LH

Data type

text

Alias
UMLS CUI [1]
C0202123
FSH
Description

FSH

Data type

text

Alias
UMLS CUI [1]
C0202022
Estradiol
Description

(Females only)

Data type

text

Alias
UMLS CUI [1]
C0337434
Prolactin
Description

Prolactin

Data type

text

Alias
UMLS CUI [1]
C0373706
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Similar models

Follow-up

1 forms
  1. StudyEvent: ODM
    1. Follow-up
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
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
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)
Office Use 1
Item
Office Use 1
boolean
C0442603 (UMLS CUI [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, 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)
White blood cell count
Item
White blood cell count (WBC)
text
C0023508 (UMLS CUI [1])
Red blood cell count
Item
Red blood cell count (RBC)
text
C0014772 (UMLS CUI [1])
Haemoglobin
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Neutrophil count
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count
Item
Lymphocytes
text
C0200635 (UMLS CUI [1])
Monocyte count
Item
Monocytes
text
C0200637 (UMLS CUI [1])
Eosinophil count
Item
Eosinophils
text
C0200638 (UMLS CUI [1])
Basophil count
Item
Basophis
text
C0200641 (UMLS CUI [1])
Platelet count
Item
Platelets
text
C0032181 (UMLS CUI [1])
Reticulocyte count
Item
Reticulocytes
text
C0206161 (UMLS CUI [1])
Mean cell volume
Item
Mean cell volume (MCV)
text
C1948043 (UMLS CUI [1])
Mean cell haemoglobin
Item
Mean cell haemoglobin (MCH)
text
C0369183 (UMLS CUI [1])
Mean cell haemoglobin concentration
Item
Mean cell haemoglobin concentration (MCHC)
text
C0474535 (UMLS CUI [1])
Item Group
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, 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)
Alkaline phosphatase
Item
Alkaline phasphatase
text
C0201850 (UMLS CUI [1])
Alanine transaminase
Item
Alanine transaminase
text
C0201836 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
text
C0201913 (UMLS CUI [1])
Direct Bilirubin
Item
Direct Bilirubin
text
C0201916 (UMLS CUI [1])
Glucose
Item
Glucose
text
C0337438 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
text
C0202035 (UMLS CUI [1])
Total protein
Item
Total protein
text
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
text
C0201838 (UMLS CUI [1])
Potassium
Item
Potassium
text
C0202194 (UMLS CUI [1])
Sodium
Item
Sodium
text
C0337443 (UMLS CUI [1])
Chloride
Item
Chloride
text
C0201952 (UMLS CUI [1])
Urea
Item
Urea
text
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
text
C0201975 (UMLS CUI [1])
Calcium
Item
Calcium
text
C0201925 (UMLS CUI [1])
Bicarbonate
Item
Bicarbonate
text
C0202059 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
text
C0202236 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
text
C0201950 (UMLS CUI [1])
LDL
Item
LDL
text
C0428474 (UMLS CUI [1])
HDL
Item
HDL
text
C0428472 (UMLS CUI [1])
Uric Acid
Item
Uric Acid
text
C0202239 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
text
C0201850 (UMLS CUI [1])
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, 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)
Urine Protein
Item
Urine Protein
text
C0430371 (UMLS CUI [1])
Urine Glucose
Item
Urine Glucose
text
C0430376 (UMLS CUI [1])
Urine Ketones
Item
Urine Ketones
text
C0430377 (UMLS CUI [1])
Urine Blood
Item
Urine Blood
text
C0430372 (UMLS CUI [1])
Urine pH
Item
Urine pH
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urine Specific Gravity
Item
Urine Specific Gravity
text
C0202517 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Item Group
Urinalysis - Local: Microscopy Details
C0430397 (UMLS CUI-1)
C0042014 (UMLS CUI-2)
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)
White blood cells
Item
White blood cells
text
C0023508 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Red Blood Cells
Item
Red Blood Cells
text
C0014772 (UMLS CUI [1,1])
C0430397 (UMLS CUI [1,2])
Hyaline casts
Item
Hyaline casts
text
C0427894 (UMLS CUI [1])
Cellular casts
Item
Cellular casts
text
C2699157 (UMLS CUI [1,1])
C0430397 (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, 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)
TSH
Item
TSH
text
C0202230 (UMLS CUI [1])
GH
Item
GH
text
C0037663 (UMLS CUI [1])
Total Testosterone
Item
Total Testosterone
text
C0202227 (UMLS CUI [1])
Free Testosterone
Item
Free Testosterone
text
C0202228 (UMLS CUI [1])
LH
Item
LH
text
C0202123 (UMLS CUI [1])
FSH
Item
FSH
text
C0202022 (UMLS CUI [1])
Estradiol
Item
Estradiol
text
C0337434 (UMLS CUI [1])
Prolactin
Item
Prolactin
text
C0373706 (UMLS CUI [1])
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