ID

37506

Description

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Keywords

Versions (2)
  1. 7/26/19 7/26/19 -
  2. 8/4/19 8/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957

English

Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

1 forms  
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
Vital Signs - Semi-Supine
Description

Vital Signs - Semi-Supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
UMLS CUI-3
C0522019
Vital Signs - Semi-Supine - Actual date/time
Description

Vital Signs - Semi-Supine - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C1264639
Systolic Blood pressure - Semi-Supine
Description

Systolic Blood pressure - Semi-Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood pressure - Semi-Supine
Description

Diastolic Blood pressure - Semi-Supine

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Temperature - Semi-supine
Description

Temperature - Semi-supine

Data type

text

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0522019
°C
Vital signs - Semi-supine - Heart rate
Description

Vital signs Predose - Semi-supine - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C0522019
beats/min
Respiration rate - Semi-Supine
Description

Respiration rate - Semi-Supine

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1,1]
C0231832
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C0522019
breaths/min
Vital Signs - Standing
Description

Vital Signs - Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0231472
Vital Signs - Standing - Actual date/time
Description

Vital Signs - Standing - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C1264639
Systolic Blood pressure - Standing
Description

Systolic Blood pressure - Standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mm[Hg]
Diastolic Blood pressure Pre-dose - Standing
Description

Diastolic Blood pressure Pre-dose - Standing

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439565
mm[Hg]
Vital signs - Standing - Heart rate
Description

Vital signs - Standing - Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C0231472
beats/min
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
12-Lead ECG - Hart rate
Description

12-Lead ECG - Hart rate

Data type

integer

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

PR Intreval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Electronically Transferred Lab Data - Dosing Date and Time
Description

Electronically Transferred Lab Data - Dosing Date and Time

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
UMLS CUI-3
C0178602
UMLS CUI-4
C0011008
UMLS CUI-5
C0040223
Electronically Transferred Lab Data - Dosing Date and Time
Description

Electronically Transferred Lab Data - Dosing Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0745590
UMLS CUI [1,2]
C1705822
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Electronically Transerred Lab Data
Description

Electronically Transerred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date and time sample taken
Description

Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sample not taken
Description

Haematology sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sample not taken
Description

Clinical Chemistry sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Serum Prolactin Date and time sample taken
Description

Serum Prolactin Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Serum Prolactin sample not taken
Description

Serum Prolactin sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0373706
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1272696
TSH Date and time sample taken
Description

TSH Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
TSH sample not taken
Description

TSH sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Testosterone Date and time sample taken
Description

Testosterone Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Testosterone sample not taken
Description

Testosterone sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Dipstick Details
Description

Urinalysis Dipstick Details

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C0439565
Urinalysis Date and time sample taken
Description

Urinalysis Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Sample not taken
Description

Urinalysis Sample not taken

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Dipstick - pH
Description

Urinalysis Dipstick - pH

Data type

integer

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
Urinalysis Dipstick - pHN umeric Result
Description

Urinalysis Dipstick - pH Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - pH Character Result
Description

Urinalysis Dipstick - pH Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Specific Gravity
Description

Urinalysis Dipstick - Specific Gravity

Data type

integer

Alias
UMLS CUI [1]
C0430383
Urinalysis Dipstick - Specific Gravitiy Numeric Result
Description

Urinalysis Dipstick - Specific Gravitiy Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430383
UMLS CUI [1,2]
C2347373
Urinalysis Dipstick - Specific Gravitiy Character Result
Description

Urinalysis Dipstick - Specific Gravitiy Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430383
UMLS CUI [1,2]
C2350015
Urinalysis Dipstick - Protein
Description

Urinalysis Dipstick - Protein

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
Urinalysis Dipstick - Protein Numeric Result
Description

Urinalysis Dipstick - Protein Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - Protein Character Result
Description

Urinalysis Dipstick - Protein Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0262923
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Glucose
Description

Urinalysis Dipstick - Glucose

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
Urinalysis Dipstick - Glucose Numeric Result
Description

Urinalysis Dipstick - Glucose Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - Glucose Character Result
Description

Urinalysis Dipstick - Glucose Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0004076
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - Ketones
Description

Urinalysis Dipstick - Ketones

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
Urinalysis Dipstick - Ketones Numeric Result
Description

Urinalysis Dipstick - Ketones Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
UMLS CUI [1,3]
C0332307
Urinalysis Dipstick - Ketones Character Result
Description

Urinalysis Dipstick - Ketones Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C1991100
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - RBC
Description

Urinalysis Dipstick - RBC

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
Urinalysis Dipstick - RBC Numeric Result
Description

Urinalysis Dipstick - RBC Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - RBC Character Result
Description

Urinalysis Dipstick - RBC Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2350015
Urinalysis Dipstick - WBC
Description

Urinalysis Dipstick - WBC

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
Urinalysis Dipstick - WBC Numeric Result
Description

Urinalysis Dipstick - WBC Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2347373
Urinalysis Dipstick - WBC Character Result
Description

Urinalysis Dipstick - WBC Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2350015
Result of dipstick
Description

Result of dipstick

Data type

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
If positive urine dipstick result, was sedimentary microscopy performed?
Description

If yes, provide details on the MICROSCOPY form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
UMLS CUI [2,1]
C0430397
UMLS CUI [2,2]
C2700128
Urinalysis - Microscopy Details
Description

Urinalysis - Microscopy Details

Alias
UMLS CUI-1
C0430397
Urinalysis Microscopy - Date and time sample taken
Description

Urinalysis Microscopy - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0200345
Urinalysis Microscopy - White blood cells
Description

Urinalysis Microscopy - White blood cells

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
Urinalysis Microscopy - White blood cells Numeric Result
Description

Urinalysis Microscopy - White blood cells Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - White blood cells Character Result
Description

Urinalysis Microscopy - White blood cells Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Red blood cells
Description

Urinalysis Microscopy - Red blood cells

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
Urinalysis Microscopy - Red blood cells Numeric Result
Description

Urinalysis Microscopy - Red blood cells Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Red blood cells Character Result
Description

Urinalysis Microscopy - Red blood cells Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0014772
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Hyaline casts
Description

Urinalysis Microscopy - Hyaline casts

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
Urinalysis Microscopy - Hyaline casts Numeric Result
Description

Urinalysis Microscopy - Hyaline casts Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Hyaline casts Character Result
Description

Urinalysis Microscopy - Hyaline casts Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C1254537
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Granular casts
Description

Urinalysis Microscopy - Granular casts

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
Urinalysis Microscopy - Granular casts Numeric Result
Description

Urinalysis Microscopy - Granular casts Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Granular casts Character Result
Description

Urinalysis Microscopy - Granular casts Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2697521
UMLS CUI [1,3]
C2350015
Urinalysis Microscopy - Cellular casts
Description

Urinalysis Microscopy - Cellular casts

Data type

integer

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
Urinalysis Microscopy - Cellular casts Numeric Result
Description

Urinalysis Microscopy - Cellular casts Numeric Result

Data type

float

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
UMLS CUI [1,3]
C2347373
Urinalysis Microscopy - Cellular casts Character Result
Description

Urinalysis Microscopy - Cellular casts Character Result

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C2699157
UMLS CUI [1,3]
C2350015
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Description

Date of last contact

Data type

date

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

Was the subject withdrawn from the study?

Data type

boolean

Alias
UMLS CUI [1]
C0422727
If the subject withdrawn from the study, record 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
If the subject withdrawn from the study, record primary Reason for Withdrawal.
Description

Primary Reason for Withdrawal

Data type

integer

Case book ready for signature
Description

Data owner shouid check the box when data cieaning is complete.

Data type

text

Alias
UMLS CUI [1]
C1519316
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Description

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

Data type

text

Alias
UMLS CUI [1]
C0919624
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Similar models

Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

1 forms
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
Vital Signs - Semi-Supine
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0522019 (UMLS CUI-3)
Vital Signs - Semi-Supine - Actual date/time
Item
Vital Signs - Semi-Supine - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Systolic Blood pressure - Semi-Supine
Item
Systolic Blood pressure - Semi-Supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood pressure - Semi-Supine
Item
Diastolic Blood pressure - Semi-Supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Temperature - Semi-supine
Item
Temperature - Semi-supine
text
C0005903 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Vital signs Predose - Semi-supine - Heart rate
Item
Vital signs - Semi-supine - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])
Respiration rate - Semi-Supine
Item
Respiration rate - Semi-Supine
integer
C0231832 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,3])
Item Group
Vital Signs - Standing
C0518766 (UMLS CUI-1)
C0231472 (UMLS CUI-2)
Vital Signs - Standing - Actual date/time
Item
Vital Signs - Standing - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Systolic Blood pressure - Standing
Item
Systolic Blood pressure - Standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic Blood pressure Pre-dose - Standing
Item
Diastolic Blood pressure Pre-dose - Standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Vital signs - Standing - Heart rate
Item
Vital signs - Standing - Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,3])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
12-Lead ECG - Hart rate
Item
12-Lead ECG - Hart rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Intreval
Item
PR Intreval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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 (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) (3)
CL Item
No result (not available) (4)
Item Group
Electronically Transferred Lab Data - Dosing Date and Time
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
C0040223 (UMLS CUI-5)
Electronically Transferred Lab Data - Dosing Date and Time
Item
Electronically Transferred Lab Data - Dosing Date and Time
datetime
C0745590 (UMLS CUI [1,1])
C1705822 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Electronically Transerred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
datetime
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Haematology sample not taken
integer
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample not taken
Code List
Haematology sample not taken
CL Item
Not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Clinical Chemistry sample not taken
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample not taken
Code List
Clinical Chemistry sample not taken
CL Item
Not done (1)
Serum Prolactin Date and time sample taken
Item
Serum Prolactin Date and time sample taken
datetime
C0373706 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Serum Prolactin sample not taken
integer
C0373706 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Serum Prolactin sample not taken
Code List
Serum Prolactin sample not taken
CL Item
Not done (1)
TSH Date and time sample taken
Item
TSH Date and time sample taken
datetime
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
TSH sample not taken
integer
C0202230 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
TSH sample not taken
Code List
TSH sample not taken
CL Item
Not done (1)
Testosterone Date and time sample taken
Item
Testosterone Date and time sample taken
datetime
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Testosterone sample not taken
integer
C0039601 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Testosterone sample not taken
Code List
Testosterone sample not taken
CL Item
Not done (1)
Item Group
Urinalysis Dipstick Details
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinalysis Sample not taken
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinalysis Sample not taken
Code List
Urinalysis Sample not taken
CL Item
Not Done (1)
Item
Urinalysis Dipstick - pH
integer
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Urinalysis Dipstick - pH
Code List
Urinalysis Dipstick - pH
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - pH Numeric Result
Item
Urinalysis Dipstick - pHN umeric Result
float
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - pH Character Result
Item
Urinalysis Dipstick - pH Character Result
text
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Specific Gravity
integer
C0430383 (UMLS CUI [1])
Urinalysis Dipstick - Specific Gravity
Code List
Urinalysis Dipstick - Specific Gravity
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Specific Gravitiy Numeric Result
Item
Urinalysis Dipstick - Specific Gravitiy Numeric Result
float
C0430383 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Urinalysis Dipstick - Specific Gravitiy Character Result
Item
Urinalysis Dipstick - Specific Gravitiy Character Result
text
C0430383 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Urinalysis Dipstick - Protein
integer
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
Urinalysis Dipstick - Protein
Code List
Urinalysis Dipstick - Protein
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Protein Numeric Result
Item
Urinalysis Dipstick - Protein Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Protein Character Result
Item
Urinalysis Dipstick - Protein Character Result
text
C0430370 (UMLS CUI [1,1])
C0262923 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Glucose
integer
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
Urinalysis Dipstick - Glucose
Code List
Urinalysis Dipstick - Glucose
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Glucose Numeric Result
Item
Urinalysis Dipstick - Glucose Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - Glucose Character Result
Item
Urinalysis Dipstick - Glucose Character Result
text
C0430370 (UMLS CUI [1,1])
C0004076 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - Ketones
integer
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
Urinalysis Dipstick - Ketones
Code List
Urinalysis Dipstick - Ketones
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - Ketones Numeric Result
Item
Urinalysis Dipstick - Ketones Numeric Result
float
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Urinalysis Dipstick - Ketones Character Result
Item
Urinalysis Dipstick - Ketones Character Result
text
C0430370 (UMLS CUI [1,1])
C1991100 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - RBC
integer
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Urinalysis Dipstick - RBC
Code List
Urinalysis Dipstick - RBC
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - RBC Numeric Result
Item
Urinalysis Dipstick - RBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - RBC Character Result
Item
Urinalysis Dipstick - RBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Dipstick - WBC
integer
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Urinalysis Dipstick - WBC
Code List
Urinalysis Dipstick - WBC
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Dipstick - WBC Numeric Result
Item
Urinalysis Dipstick - WBC Numeric Result
float
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Dipstick - WBC Character Result
Item
Urinalysis Dipstick - WBC Character Result
text
C0430370 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Result of dipstick
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Result of dipstick
Code List
Result of dipstick
CL Item
No result  (NR)
CL Item
Negative  (NEG)
CL Item
Positive (POS)
If positive urine dipstick result, was sedimentary microscopy performed?
Item
If positive urine dipstick result, was sedimentary microscopy performed?
boolean
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0430397 (UMLS CUI [2,1])
C2700128 (UMLS CUI [2,2])
Item Group
Urinalysis - Microscopy Details
C0430397 (UMLS CUI-1)
Urinalysis Microscopy - Date and time sample taken
Item
Urinalysis Microscopy - Date and time sample taken
datetime
C0430397 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
Item
Urinalysis Microscopy - White blood cells
integer
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
Urinalysis Microscopy - White blood cells
Code List
Urinalysis Microscopy - White blood cells
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - White blood cells Numeric Result
Item
Urinalysis Microscopy - White blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - White blood cells Character Result
Item
Urinalysis Microscopy - White blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Red blood cells
integer
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Urinalysis Microscopy - Red blood cells
Code List
Urinalysis Microscopy - Red blood cells
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Red blood cells Numeric Result
Item
Urinalysis Microscopy - Red blood cells Numeric Result
float
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Red blood cells Character Result
Item
Urinalysis Microscopy - Red blood cells Character Result
text
C0430397 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Hyaline casts
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
Urinalysis Microscopy - Hyaline casts
Code List
Urinalysis Microscopy - Hyaline casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Hyaline casts Numeric Result
Item
Urinalysis Microscopy - Hyaline casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Hyaline casts Character Result
Item
Urinalysis Microscopy - Hyaline casts Character Result
text
C0430397 (UMLS CUI [1,1])
C1254537 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Granular casts
integer
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
Urinalysis Microscopy - Granular casts
Code List
Urinalysis Microscopy - Granular casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Granular casts Numeric Result
Item
Urinalysis Microscopy - Granular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Granular casts Character Result
Item
Urinalysis Microscopy - Granular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2697521 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Urinalysis Microscopy - Cellular casts
integer
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
Urinalysis Microscopy - Cellular casts
Code List
Urinalysis Microscopy - Cellular casts
CL Item
Numeric result  (1)
CL Item
Character result  (2)
CL Item
No result (3)
Urinalysis Microscopy - Cellular casts Numeric Result
Item
Urinalysis Microscopy - Cellular casts Numeric Result
float
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Urinalysis Microscopy - Cellular casts Character Result
Item
Urinalysis Microscopy - Cellular casts Character Result
text
C0430397 (UMLS CUI [1,1])
C2699157 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the 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 the subject withdrawn from the study, record Date of decision to withdraw.
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If the subject withdrawn from the study, record primary Reason for Withdrawal.
integer
Primary Reason for Withdrawal
Code List
If the subject withdrawn from the study, record primary Reason for Withdrawal.
CL Item
Adverse Event (1)
CL Item
Record detaiis on the Non-Serious Adverse Events or Serious Adverse (1)
CL Item
Events forrns as appropriate. (2)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-up (5)
CL Item
Withdrew consent (6)
Item
Case book ready for signature
text
C1519316 (UMLS CUI [1])
Case book ready for signature
Code List
Case book ready for signature
CL Item
Yes (Y)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1])
Did a female partner of the male subject become pregnant during the study?
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
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